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Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (ASPIRE PAD)

Information source: North Texas Veterans Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral Arterial Disease, Antiplatelet Therapy

Intervention: ASA (75-100 mg) + clopidogrel 75 mg: 12m treatment intervention (Drug); ASA (75-100 mg) + clopidogrel: 1m (control arm) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Subhash Banerjee, MD, Study Chair, Affiliation: University of Texas Southwestern Medical Center

Overall contact:
Atif Mohammad, MD, Phone: 2147428387, Ext: 76630, Email: atif.mohammad@utsouthwestern.edu

Summary

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

Clinical Details

Official title: Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (ASPIRE PAD).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 12-month Primary Endpoint (subject-based):

Secondary outcome: Secondary Endpoints through 12 months:

Detailed description: To evaluate whether clopidogrel 75 mg QD on a background of ASA 75-100 mg/d for 12 months or for 1 month will lead to an increased rate of primary patency, limb salvage, freedom form ischemic stroke and survival, in patients receiving endovascular treatment of PAD. Trial hypothesis We hypothesize that DAPT with ASA and clopidogrel administered for 12 months following iliac, FP or BTK endovascular intervention will improve primary patency, limb salvage, freedom form ischemic stroke and survival, in patients with symptomatic PAD. Trial endpoints Clinical endpoints will be analyzed in all subjects who are enrolled, regardless of whether the trial treatment administered successfully completed for the desired duration. A subject will be considered enrolled in the trial when he/she is randomized to one of the treatment arms of the study. All endpoints are subject-based unless otherwise specified. The primary endpoint is a subject-based 12-month endpoint of the first occurrence of index limb arterial occlusion, surgical intervention, endovascular intervention, amputation of the affected limb (primary patency and limb salvage), MI, ischemic stroke or death (survival) The secondary endpoints are subject-based 12-month endpoints that include: (a) the first occurrence of any individual component of the primary endpoint, (b) the first occurrence of the following during follow-up: cardiovascular death, or MI, or ischemic stroke, or any amputation above the ankle and (c) severe bleeding defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO)classification The tertiary endpoint is based on 12-month moderate bleeding according to the GUSTO classification

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Atif Mohammad, MD, Phone: 2147428387, Ext: 76630, Email: atif.mohammad@utsouthwestern.edu

Midwest Cardiovascular Research Foundation, Davenport, Iowa, United States; Recruiting
Gail Shammas, RN, Phone: 563-324-2828, Ext: 102, Email: shammasg@mcrfmd.com
Nicolas Shammas, MD, Principal Investigator

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Atif Mohammad, MD, Phone: 214-742-8387, Ext: 76630, Email: atif.mohammad@utsouthwestern.edu
Subhash Banerjee, MD, Principal Investigator

VA North Texas Health Care System, Dallas, Texas 75216, United States; Recruiting
Atif Mohammad, MD, Phone: 214-742-8387, Ext: 76630, Email: atif.mohammad@va.gov
Subhash Banerjee, MD, Principal Investigator

Additional Information

Related publications:

Hirsch AT, Duval S. The global pandemic of peripheral artery disease. Lancet. 2013 Oct 19;382(9901):1312-4. doi: 10.1016/S0140-6736(13)61576-7. Epub 2013 Aug 1.

Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004 Jan;172(1):95-105.

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. ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Associations 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)--summary of recommendations. J Vasc Interv Radiol. 2006 Sep;17(9):1383-97; quiz 1398.

Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol. 2012 Oct 9;60(15):1352-9. doi: 10.1016/j.jacc.2012.05.042. Epub 2012 Sep 12.

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.

Starting date: October 2014
Last updated: December 11, 2014

Page last updated: August 23, 2015

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