Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
Completed · Phase 3
Conditions studied: Peripheral Arterial Disease
In brief
The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at end of study treatment.
Key facts
- Study ID
- NCT02217501
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 159
- Starts
- 2015-11-01
- Expected to finish
- 2020-01-30
- Last updated by the study team
- 2021-02-21
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- General:
- Signed informed consent
- At least 18 years old
- Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK) atherosclerotic disease (Rutherford/Becker category 2, 3 or ≥4)
- Undergone clinically indicated uncomplicated endovascular intervention to one or more locations of the iliac, femoropopliteal below-the knee arteries
- Estimated survival ≥1 year in the judgment of the primary operator
- Pre-index procedure use of ASA, clopidogrel or both at any dose
- Angiographic:
- De novo or restenotic lesions in the common and/or external iliac artery, superficial femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all target lesions if multiple)
- Subjects with multiple planned procedures can be enrolled after the completion of the last planned procedure.
You may not qualify if…
- General:
- Complicated qualifying procedure (perforation, flow limiting dissection, distal embolization requiring re-intervention, need for repeat endovascular, surgical revascularization, amputation or blood transfusion prior to hospital discharge following an index procedure
- Extended hospital stay >7 days following the index procedure
- Allergy to aspirin or clopidogrel
- Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
- Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
- Platelet count <90,000 mm3 or >600,000 mm3
- Serum creatinine >2.5 mg/dL
- Dialysis-dependent end stage renal disease
- Pregnancy
- Current participation in another drug or device trial that requires interruption of dual-antiplatelet therapy with aspirin or clopidogrel for the duration of the study
- Planned surgeries, endovascular or other non-vascular or cardiac procedures
- Concurrent warfarin or other chronic oral anticoagulant therapy
- Contraindication(s) to the use of AT (history of intra-cerebral bleed, presence of intra-cerebral mass, recent or <6 weeks gastrointestinal bleed, blood transfusion within the last 6 weeks, any trauma requiring surgery or blood transfusion within the last 4 weeks or any surgical procedure within the last 4 weeks.
- Angiographic:
- Endovascular intervention to iliac, femoropopliteal or BTK artery bypass graft
- Persistent, intraluminal thrombus of the proposed target lesion at the completion of the index procedure
- Perforated vessel as evidenced by extravasation of contrast media
- Vascular graft, aneurysm or postsurgical stenosis of the target vessel
Where it is running
- Denver VA Medical Center — Denver, Colorado, United States
- Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
- VA North Texas Health Care System — Dallas, Texas, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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