Peripheral Arterial Disease, Antiplatelet Therapy Clinical Trial
— ASPIRE PADOfficial title:
Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (ASPIRE PAD).
To evaluate whether clopidogrel 75 mg daily on a background of aspirin 75- 100 mg/d for 12 months or for 1 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 1 year
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 index procedure - Extended hospital stay >7 days following the index procedure - Allergy to aspirin or clopidogrel - MI or PCI with DES within the past 9 months - 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 <1y - Planned surgeries, endovascular or other non-vascular or cardiac procedures - Warfarin or other chronic oral anticoagulant use - Contraindication(s) to the use of antithrombin or antiplatelet agents (history of intra-cerebral bleed, presence of intracerebral 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: Angiographic: - Endovascular intervention to iliac, FB 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | VA North Texas Health Care System | Dallas | Texas |
| United States | Midwest Cardiovascular Research Foundation | Davenport | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| University of Texas Southwestern Medical Center |
United States,
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Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Tertiary outcome 12 month | Moderate bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification | 12 month | Yes |
| Primary | 12-month Primary Endpoint (subject-based): | The first occurrence of index limb arterial occlusion, surgical intervention, endovascular intervention, amputation of the affected limb (vessel occlusion or failure), MI, ischemic stroke or death | 12 months | Yes |
| Secondary | Secondary Endpoints through 12 months: | The first occurrence of any individual component of the primary endpoint First occurrence of the following during follow-up: cardiovascular death, or MI, or ischemic stroke, or any amputation above the ankle. Severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification |
12 months | Yes |