Trial Outcomes & Findings for EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA (NCT NCT00562588)
NCT ID: NCT00562588
Last Updated: 2014-03-19
Results Overview
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
551 participants
Primary outcome timeframe
90 days
Results posted on
2014-03-19
Participant Flow
551 patients enrolled, 548 randomized, 543 treated; analysis is based on treated patients
Participant milestones
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Overall Study
STARTED
|
260
|
283
|
|
Overall Study
COMPLETED
|
168
|
184
|
|
Overall Study
NOT COMPLETED
|
92
|
99
|
Reasons for withdrawal
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Overall Study
Adverse Event
|
40
|
58
|
|
Overall Study
Protocol Violation
|
30
|
26
|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
Baseline characteristics by cohort
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=260 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=283 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
66.5 Years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
67.3 Years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
339 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=254 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=273 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
0
|
58 participants
|
70 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
1
|
75 participants
|
84 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
2
|
50 participants
|
62 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
3
|
30 participants
|
16 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
4
|
31 participants
|
32 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
5
|
6 participants
|
4 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
6
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=238 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=262 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)
|
-2 Units on a scale
Interval -4.0 to 0.0
|
-2 Units on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=260 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=283 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)
|
38 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 8 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=254 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=273 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
0
|
46 participants
|
47 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
1
|
59 participants
|
74 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
2
|
42 participants
|
52 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
3
|
39 participants
|
38 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
4
|
51 participants
|
44 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
5
|
12 participants
|
8 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
6
|
0 participants
|
2 participants
|
|
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
Missing
|
5 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline and 8 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=236 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=255 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8
|
-1.0 units on a scale
Interval -3.0 to 0.0
|
-1.0 units on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: 8 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=213 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=212 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change of Special Biochemical Laboratory Value- CRP
|
1.27 mg/L
Interval 1.06 to 1.52
|
1.17 mg/L
Interval 1.0 to 1.38
|
SECONDARY outcome
Timeframe: 8 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=213 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=212 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change of Special Biochemical Laboratory Value- MMP-9
|
0.974 ng/mL
Interval 0.884 to 1.07
|
0.983 ng/mL
Interval 0.89 to 1.08
|
SECONDARY outcome
Timeframe: 8 daysPopulation: FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.
Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=213 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=212 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change of Special Biochemical Laboratory Value - MCP-1
|
1.06 µg/mL
Interval 1.01 to 1.1
|
1.08 µg/mL
Interval 1.03 to 1.13
|
SECONDARY outcome
Timeframe: Baseline and day 8Population: Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 8.
MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=116 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=111 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8
|
0.4100 mL
Interval 0.105 to 2.045
|
0.3300 mL
Interval 0.02 to 1.35
|
SECONDARY outcome
Timeframe: Baseline and day 90Population: Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 90.
MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=101 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=90 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.
|
0.1900 mL
Interval 0.0 to 1.14
|
0.1150 mL
Interval 0.0 to 0.9
|
SECONDARY outcome
Timeframe: Baseline and day 8Population: Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 8.
MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=120 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=117 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8
|
-0.0600 mL
Interval -0.705 to 0.565
|
0.0000 mL
Interval -0.5 to 0.3
|
SECONDARY outcome
Timeframe: Baseline and day 90Population: Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 90.
MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.
Outcome measures
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=80 Participants
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=70 Participants
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90
|
-0.8400 mL
Interval -2.085 to -0.355
|
-0.7100 mL
Interval -1.93 to -0.26
|
Adverse Events
Aspirin for 7 Days, Followed by Aggrenox
Serious events: 48 serious events
Other events: 60 other events
Deaths: 0 deaths
Aggrenox
Serious events: 45 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=260 participants at risk
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=283 participants at risk
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
5.8%
15/260 • Up to 90 days
From first drug intake until date of last drug intake
|
1.8%
5/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Carotid artery stenosis
|
1.9%
5/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.71%
2/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
4/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.71%
2/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
3/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Hemiplegia
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.71%
2/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Status epilepticus
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Aphasia
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Brain stem stroke
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Convulsion
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Hyponatraemic encephalopathy
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Neurological symptom
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Nervous system disorders
Somnolence
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Atrial fibrillation
|
0.77%
2/260 • Up to 90 days
From first drug intake until date of last drug intake
|
1.1%
3/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Myocardial infarction
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
1.4%
4/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Cardiac failure
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
1.1%
3/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.71%
2/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Angina pectoris
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Angina unstable
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Arrhythmia
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Cardiac arrest
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Ventricular dyskinesia
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Pneumonia
|
1.2%
3/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Appendicitis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Endocarditis
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Pseudomonas infection
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Staphylococcal infection
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Infections and infestations
Urosepsis
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
1.2%
3/260 • Up to 90 days
From first drug intake until date of last drug intake
|
1.1%
3/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.71%
2/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Psychiatric disorders
Depression
|
0.77%
2/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Psychiatric disorders
Delirium
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Psychiatric disorders
Major depression
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Vascular disorders
Hypertension
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Vascular disorders
Hypertensive crisis
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Vascular disorders
Ischaemia
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Vascular disorders
Thrombosis
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Eye disorders
Vitreous haemorrhage
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
General disorders
Chest pain
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.38%
1/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.00%
0/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Surgical and medical procedures
Arterial repair
|
0.00%
0/260 • Up to 90 days
From first drug intake until date of last drug intake
|
0.35%
1/283 • Up to 90 days
From first drug intake until date of last drug intake
|
Other adverse events
| Measure |
Aspirin for 7 Days, Followed by Aggrenox
n=260 participants at risk
ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
Aggrenox
n=283 participants at risk
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|---|---|---|
|
Nervous system disorders
Headache
|
20.4%
53/260 • Up to 90 days
From first drug intake until date of last drug intake
|
37.1%
105/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Gastrointestinal disorders
Nausea
|
5.4%
14/260 • Up to 90 days
From first drug intake until date of last drug intake
|
10.2%
29/283 • Up to 90 days
From first drug intake until date of last drug intake
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
10/260 • Up to 90 days
From first drug intake until date of last drug intake
|
9.2%
26/283 • Up to 90 days
From first drug intake until date of last drug intake
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER