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Trial record 93 of 602 for:    ASPIRIN AND clopidogrel

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

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ClinicalTrials.gov Identifier: NCT02217501
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Clopidogrel Drug: Acetylsalicylic acid (ASA) Phase 3

Detailed Description:

Peripheral arterial disease (PAD) is extremely prevalent worldwide and affects over 206 million people. Over 36 million patients with PAD are estimated to be present in the United States. Percutaneous revascularization therapies have evolved dramatically, yet the long-term success of these therapies remains modest and the morbidity and mortality associated with PAD remains high, with up to 30% mortality risk at 5 years. Nearly, 3.2 million endovascular procedures are performed annually. Though, this exceeds interventional procedures performed for coronary artery disease (CAD), the current PAD guidelines are silent regarding the need and optimal duration of antiplatelet therapy (APT) for patients following an endovascular procedure for claudication or critical limb ischemia (CLI). The lack of data and clinical studies is by far the greatest impediment to the formulation of such guideline recommendations critically needed by providers and patients alike, especially given the current limited durability of lower extremity endovascular procedures.

The objective of this trial is to evaluate whether clopidogrel 75 mg QD on a background of ASA 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.

The investigators hypothesize that dual antiplatelet therapy (DAPT) with ASA and clopidogrel administered for an additional 12 months following iliac, femoropopliteal or below the knee endovascular intervention will improve primary patency, limb salvage, freedom from ischemic stroke and survival, in patients with symptomatic PAD.

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 subject-based of the longer of a 12-month or end of study treatment 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 on the longer of a 12 month or end of study treatment 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 the longer of a 12-month or end of study moderate bleeding according to the GUSTO classification.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
Study Start Date : November 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Clopidogrel
Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Other Name: Plavix

Drug: Acetylsalicylic acid (ASA)
Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Other Name: Aspirin

Active Comparator: 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
Drug: Clopidogrel
Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Other Name: Plavix

Drug: Acetylsalicylic acid (ASA)
Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
Other Name: Aspirin




Primary Outcome Measures :
  1. First occurrence of target vessel occlusion, surgical revascularization, endovascular revascularization, major amputation of target limb, ischemic stroke, MI, or death [ Time Frame: 12 months from index procedure or end of study treatment, whichever is longer ]
    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.


Secondary Outcome Measures :
  1. First occurrence of bleeding [ Time Frame: 12 months or end of study treatment, whichever is longer ]

    Any 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217501


Locations
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United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Subhash Banerjee, MD University of Texas Southwestern Medical Center
Study Chair: Subhash Banerjee, MD University of Texas Southwestern Medical Center

Publications:
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.
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.

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02217501     History of Changes
Obsolete Identifiers: NCT02317822
Other Study ID Numbers: 122013-065
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be posted on clinical.trials.gov and through publications and presentations

Keywords provided by University of Texas Southwestern Medical Center:
peripheral arterial disease, antiplatelet therapy

Additional relevant MeSH terms:
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Clopidogrel
Aspirin
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics