Trial Outcomes & Findings for Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention (NCT NCT02508116)
NCT ID: NCT02508116
Last Updated: 2018-11-07
Results Overview
The number (percentage) of participants receiving prasugrel/ticagrelor in each randomized arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
509 participants
Primary outcome timeframe
for up to 7 days after PCI
Results posted on
2018-11-07
Participant Flow
Patients, age ≥18 to ≤80 years at time of study, who were underwent PCI between November 2014 and August 2016 at the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center.
Participant milestones
| Measure |
CYP2C19 Genotype Guided
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Overall Study
STARTED
|
252
|
257
|
|
Overall Study
Received Intervention as Randomized
|
249
|
255
|
|
Overall Study
COMPLETED
|
244
|
250
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
CYP2C19 Genotype Guided
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention
Baseline characteristics by cohort
| Measure |
CYP2C19 Genotype Guided
n=249 Participants
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=255 Participants
Antiplatelet therapy will be decided based on usual care
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
62.9 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
62.9 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
370 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
194 Participants
n=99 Participants
|
197 Participants
n=107 Participants
|
391 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
48 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
249 participants
n=99 Participants
|
255 participants
n=107 Participants
|
504 participants
n=206 Participants
|
|
Hospital Site
Hospital of the University of Pennsylvania
|
135 Participants
n=99 Participants
|
141 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Hospital Site
Penn Presbyterian Hospital
|
114 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Acute coronary syndrome
|
124 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Insurance Status
Public
|
100 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
210 Participants
n=206 Participants
|
|
Insurance Status
Other
|
149 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
294 Participants
n=206 Participants
|
|
Work Status
Full time
|
88 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Work Status
Retired
|
84 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Work Status
Disabled
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Work Status
Not provided
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Work Status
Other/unknown
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Tobacco use
Never
|
114 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
237 Participants
n=206 Participants
|
|
Tobacco use
Former
|
105 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Tobacco use
Current
|
28 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Tobacco use
unknown
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Medical history
Hypertension
|
190 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
389 Participants
n=206 Participants
|
|
Medical history
Hypercholesterolemia
|
112 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Medical history
Diabetes Mellitus
|
89 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Medical history
Previous MI
|
63 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Medical history
Previous PCI
|
83 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Medical history
Previous CABG
|
32 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Medical history
Previous Stroke
|
7 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
P2Y12 inhibitor use prior to admission
Clopidogrel
|
80 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
P2Y12 inhibitor use prior to admission
Prasugrel
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
P2Y12 inhibitor use prior to admission
Ticagrelor
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
P2Y12 inhibitor use prior to admission
None
|
155 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Pharmacotherapy prior to admission
Aspirin
|
165 Participants
n=99 Participants
|
157 Participants
n=107 Participants
|
322 Participants
n=206 Participants
|
|
Pharmacotherapy prior to admission
ACE inhibitor or ARB
|
115 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Pharmacotherapy prior to admission
Beta-blocker
|
121 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
Pharmacotherapy prior to admission
Calcium channel blocker
|
50 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Pharmacotherapy prior to admission
Statin
|
112 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Pharmacotherapy prior to admission
Other anti-anginal
|
83 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: for up to 7 days after PCIPopulation: Intent to treat
The number (percentage) of participants receiving prasugrel/ticagrelor in each randomized arm
Outcome measures
| Measure |
CYP2C19 Genotype Guided
n=249 Participants
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=255 Participants
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor
Clopidogrel
|
174 Participants
|
201 Participants
|
|
The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor
Prasugrel/ticagrelor
|
75 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: for up to 7 days after PCIPopulation: Subjects with genotype data available
Agreement to suggested treatment recommendations based on genotype. The agreement rate was defined as the number of participants in genotyped group with loss of function variants that received prasugrel or ticagrelor + the number of participants without these variants that received clopidogrel divided by the total number in this group.
Outcome measures
| Measure |
CYP2C19 Genotype Guided
n=242 Participants
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=226 Participants
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Number of Participants With Drug Orders in Agreement With the Genotype-guided Recommendations
|
172 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent to treat
major cardiac events defined as occurrence of first myocardial infarction, ischemic stroke, cardiovascular death, stent thrombosis, or need for urgent revascularization
Outcome measures
| Measure |
CYP2C19 Genotype Guided
n=249 Participants
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=255 Participants
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Number of Participants With Major Cardiac Events
|
34 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 1 yearmajor bleeding events defined by the Bleeding Academic Research Consortium (BARC) type 3 or 5. Type 3= Overt bleeding requiring: blood transfusion, surgical intervention or intravenous vasoactive agents; cardiac tamponade; intracranial hemorrhage; intraocular bleeding. Type 5= fatal bleeding
Outcome measures
| Measure |
CYP2C19 Genotype Guided
n=249 Participants
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=255 Participants
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Number of Participants With Bleeding Events
|
6 Participants
|
7 Participants
|
Adverse Events
CYP2C19 Genotype Guided
Serious events: 132 serious events
Other events: 28 other events
Deaths: 8 deaths
Control Group
Serious events: 115 serious events
Other events: 34 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
CYP2C19 Genotype Guided
n=249 participants at risk
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=255 participants at risk
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.80%
2/249 • Number of events 2 • 1 year
|
1.2%
3/255 • Number of events 3 • 1 year
|
|
Cardiac disorders
angina pectoris
|
13.3%
33/249 • Number of events 33 • 1 year
|
8.2%
21/255 • Number of events 21 • 1 year
|
|
Cardiac disorders
angina unstable
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Cardiac disorders
atrial fibrillation
|
1.6%
4/249 • Number of events 4 • 1 year
|
1.2%
3/255 • Number of events 3 • 1 year
|
|
Cardiac disorders
bradyarrhythmia
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Cardiac disorders
bradycardia
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Cardiac disorders
cardiac arrest
|
1.2%
3/249 • Number of events 3 • 1 year
|
0.00%
0/255 • 1 year
|
|
Cardiac disorders
cardiac failure
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Cardiac disorders
cardiac failure congestive
|
1.2%
3/249 • Number of events 3 • 1 year
|
1.6%
4/255 • Number of events 4 • 1 year
|
|
Cardiac disorders
cardiomyopathy
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Cardiac disorders
myocardial infarction
|
3.2%
8/249 • Number of events 8 • 1 year
|
4.3%
11/255 • Number of events 11 • 1 year
|
|
Cardiac disorders
pericarditis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Cardiac disorders
tachyarrhytmia
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Injury, poisoning and procedural complications
stent thrombosis
|
0.40%
1/249 • Number of events 1 • 1 year
|
2.0%
5/255 • Number of events 5 • 1 year
|
|
Cardiac disorders
ventricular arrythmia
|
1.2%
3/249 • Number of events 3 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/249 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
gastrointestinal hemmorhage
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
gastrointestinal ulcer
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
hemorrhoids
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
hernia
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
inguinal hernia
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
melena
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
nausea
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
rectal hemorrhage
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.00%
0/255 • 1 year
|
|
General disorders
drug intolerance
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
bile duct stone
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Cardiac disorders
cardiac transplantation
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Immune system disorders
lung transplant rejection
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
bronchitis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
cellulitis
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
endocarditis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
groin abscess
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Infections and infestations
influenza
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
osteomyelitis
|
0.00%
0/249 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Infections and infestations
pneumonia
|
1.6%
4/249 • Number of events 4 • 1 year
|
2.0%
5/255 • Number of events 5 • 1 year
|
|
Infections and infestations
septic shock
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Injury, poisoning and procedural complications
coronary artery restenosis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
fall
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
subdural hematoma
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
tibia fracture
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Investigations
hemoglobin decrease
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
rhabdomyolysis
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
spinal stenosis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
rectal mass
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid cancer
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Nervous system disorders
dizziness
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Nervous system disorders
epilepsy
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Nervous system disorders
ischemic stroke
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Nervous system disorders
polyneuropathy
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Nervous system disorders
syncope
|
1.2%
3/249 • Number of events 3 • 1 year
|
0.00%
0/255 • 1 year
|
|
Nervous system disorders
transient ischemic attack
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Psychiatric disorders
confusional state
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
acute renal failure
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/249 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
urinary retention
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
1.2%
3/249 • Number of events 3 • 1 year
|
1.6%
4/255 • Number of events 4 • 1 year
|
|
Surgical and medical procedures
amputation
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
angioplasty
|
2.0%
5/249 • Number of events 5 • 1 year
|
1.2%
3/255 • Number of events 3 • 1 year
|
|
Surgical and medical procedures
aortic valve replacement
|
1.2%
3/249 • Number of events 3 • 1 year
|
0.00%
0/255 • 1 year
|
|
Surgical and medical procedures
coronary artery bypass grafting
|
2.0%
5/249 • Number of events 5 • 1 year
|
1.2%
3/255 • Number of events 3 • 1 year
|
|
Surgical and medical procedures
gastrectomy
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Surgical and medical procedures
implantable defibrillator implantation
|
2.4%
6/249 • Number of events 6 • 1 year
|
0.00%
0/255 • 1 year
|
|
Surgical and medical procedures
knee arthroplasty
|
1.2%
3/249 • Number of events 3 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
mitral valve repair
|
0.00%
0/249 • 1 year
|
1.2%
3/255 • Number of events 3 • 1 year
|
|
Surgical and medical procedures
rotator cuff repair
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Surgical and medical procedures
percutaneous coronary intervention
|
1.6%
4/249 • Number of events 4 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Vascular disorders
aortic aneursym
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Vascular disorders
aortic dissection
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Vascular disorders
hypotension
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Vascular disorders
peripheral arterial occlusive disease
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Vascular disorders
peripheral vascular disorder
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 3 • 1 year
|
Other adverse events
| Measure |
CYP2C19 Genotype Guided
n=249 participants at risk
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
CYP2C19 genotyping: The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
|
Control Group
n=255 participants at risk
Antiplatelet therapy will be decided based on usual care
|
|---|---|---|
|
Cardiac disorders
angina pectoris
|
2.4%
6/249 • Number of events 6 • 1 year
|
4.3%
11/255 • Number of events 11 • 1 year
|
|
Cardiac disorders
atrial fibrillation
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.00%
0/255 • 1 year
|
|
Cardiac disorders
palpitation
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Gastrointestinal disorders
hematemesis
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
melena
|
0.00%
0/249 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
mouth swelling
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
General disorders
drug intolerance
|
0.00%
0/249 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
General disorders
malaise
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
edema peripheral
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Infections and infestations
abscess
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Infections and infestations
urinary tract infection
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Injury, poisoning and procedural complications
upper limb injury
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Injury, poisoning and procedural complications
contusion
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Injury, poisoning and procedural complications
fall
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Nervous system disorders
dizziness
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Nervous system disorders
headache
|
0.00%
0/249 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
calculus ureteric
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
dyspnea
|
0.00%
0/249 • 1 year
|
1.2%
3/255 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Eye disorders
eye hemorrhage
|
0.00%
0/249 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Eye disorders
eye pain
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.00%
0/255 • 1 year
|
|
Musculoskeletal and connective tissue disorders
dental pain
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.00%
0/255 • 1 year
|
|
Musculoskeletal and connective tissue disorders
gouty arthritis
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.80%
2/249 • Number of events 2 • 1 year
|
0.78%
2/255 • Number of events 2 • 1 year
|
|
Psychiatric disorders
confusional state
|
0.40%
1/249 • Number of events 1 • 1 year
|
0.39%
1/255 • Number of events 1 • 1 year
|
Additional Information
Sony Tuteja, PharmD, MS
University of Pennsylvania School of Medicine
Phone: 215-573-7834
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place