Trial Outcomes & Findings for Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (NCT NCT02217501)
NCT ID: NCT02217501
Last Updated: 2021-02-21
Results Overview
Occlusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
159 participants
Primary outcome timeframe
12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 years
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
DAPT - Clinically Indicated Duration
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
DAPT - Clinically Indicated Duration+12m
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
77
|
|
Overall Study
COMPLETED
|
78
|
74
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
DAPT - Clinically Indicated Duration
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
DAPT - Clinically Indicated Duration+12m
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
|---|---|---|
|
Overall Study
Death
|
4
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DAPT - Clinically Indicated Duration+12m
n=77 Participants
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
DAPT - Clinically Indicated Duration
n=82 Participants
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.62 years
STANDARD_DEVIATION 8.82 • n=77 Participants
|
65.27 years
STANDARD_DEVIATION 8.90 • n=82 Participants
|
65.44 years
STANDARD_DEVIATION 9.00 • n=159 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=77 Participants
|
14 Participants
n=82 Participants
|
26 Participants
n=159 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=77 Participants
|
68 Participants
n=82 Participants
|
133 Participants
n=159 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 yearsOcclusion of the target vessel documented by any imaging procedure (eg, Duplex ultrasonography scan including B mode imaging and Doppler ultrasound scan) at any follow-up visit within 12 months or end of study treatment period, whichever is longer.
Outcome measures
| Measure |
DAPT - Clinically Indicated Duration+12m
n=77 Participants
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
DAPT - Clinically Indicated Duration
n=82 Participants
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
|---|---|---|
|
Number of Participants With First Occurrence of Target Vessel Occlusion, Surgical Revascularization, Endovascular Revascularization, Major Amputation of Target Limb, Ischemic Stroke, MI, or Death
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 12 months from index procedure or end of study treatment, whichever is longer, assessed up to 2 yearsAny mild, moderate, severe, or life-threatening bleeding. Severe or Life-threatening: Intracerebral hemorrhage Resulting in substantial hemodynamic compromise requiring treatment Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise Mild: Bleeding that does not meet above criteria Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification.
Outcome measures
| Measure |
DAPT - Clinically Indicated Duration+12m
n=77 Participants
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
DAPT - Clinically Indicated Duration
n=82 Participants
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
|---|---|---|
|
Number of Participants With First Occurrence of Bleeding
|
5 Participants
|
4 Participants
|
Adverse Events
DAPT - Clinically Indicated Duration+12m
Serious events: 27 serious events
Other events: 1 other events
Deaths: 3 deaths
DAPT - Clinically Indicated Duration
Serious events: 37 serious events
Other events: 1 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
DAPT - Clinically Indicated Duration+12m
n=77 participants at risk
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
DAPT - Clinically Indicated Duration
n=82 participants at risk
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
1/77 • Number of events 1 • Adverse events were collected from the time on informed consent and up to 18 months.
|
3.7%
3/82 • Number of events 3 • Adverse events were collected from the time on informed consent and up to 18 months.
|
|
Blood and lymphatic system disorders
Stroke
|
1.3%
1/77 • Number of events 1 • Adverse events were collected from the time on informed consent and up to 18 months.
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the time on informed consent and up to 18 months.
|
|
Vascular disorders
Repeat Endovascular Revascularization
|
16.9%
13/77 • Number of events 13 • Adverse events were collected from the time on informed consent and up to 18 months.
|
19.5%
16/82 • Number of events 16 • Adverse events were collected from the time on informed consent and up to 18 months.
|
|
Surgical and medical procedures
Amputation
|
9.1%
7/77 • Number of events 7 • Adverse events were collected from the time on informed consent and up to 18 months.
|
14.6%
12/82 • Number of events 12 • Adverse events were collected from the time on informed consent and up to 18 months.
|
|
Blood and lymphatic system disorders
Bleeding
|
3.9%
3/77 • Number of events 3 • Adverse events were collected from the time on informed consent and up to 18 months.
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the time on informed consent and up to 18 months.
|
|
Surgical and medical procedures
Bleeding requiring transfusion
|
2.6%
2/77 • Number of events 2 • Adverse events were collected from the time on informed consent and up to 18 months.
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the time on informed consent and up to 18 months.
|
Other adverse events
| Measure |
DAPT - Clinically Indicated Duration+12m
n=77 participants at risk
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration plus an additional 12 months
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
|
DAPT - Clinically Indicated Duration
n=82 participants at risk
Clopidogrel 75 mg daily and Acetylsalicylic acid (ASA) 75-100 mg daily for clinically indicated duration with a minimum of 30 days
Clopidogrel: Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration
Acetylsalicylic acid (ASA): Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration
|
|---|---|---|
|
Surgical and medical procedures
CT/MR Angiography
|
1.3%
1/77 • Number of events 1 • Adverse events were collected from the time on informed consent and up to 18 months.
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the time on informed consent and up to 18 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place