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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

Tracking Information
First Submitted Date  ICMJE August 1, 2014
First Posted Date  ICMJE August 15, 2014
Last Update Posted Date June 4, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2014)
  • Target vessel occlusion [ Time Frame: 12 months ]
    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 after the index procedure.
  • Surgical revascularization [ Time Frame: 12 months ]
    Any open surgical revascularization (surgical bypass, endarterectomy, or patch angioplasty) of the index limb within the 12-month follow-up time period.
  • Endovascular revascularization [ Time Frame: 12 months ]
    Any endovascular revascularization of the target limb using a stent or non-stent based strategy within the 12-month follow-up time period. This includes a failed attempt at endovascular revascularization; i.e. if the lesion could not be crossed, if the devices could not be implanted, if complications caused premature abortion of the procedure, etc.
  • Major amputation of the target limb [ Time Frame: 12 months ]
    Any major amputation of the target limb, such as a below-the-knee, through-knee, or above-the-knee amputation within the 12-month follow-up time period.
  • Ischemic Stroke [ Time Frame: 12 months ]
    An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction confirmed by a neurologist within the 12-month follow-up time period.
  • Myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction: Detection of a rise in cardiac troponin (cTn) with at least one value 3x above the 99th percentile upper reference limit (URL) and with at least 1 of the following:
    • Symptoms of ischemia
    • New or presumed new significant (≥1 mm) ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB)
    • Development of pathological Q waves in the ECG
  • Death [ Time Frame: 12 months ]
    All-cause mortality within the 12-month follow-up time period.
Change History Complete list of historical versions of study NCT02217501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2014)
Bleeding [ Time Frame: 12 months ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
Official Title  ICMJE Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Clopidogrel
    • Drug: Acetylsalicylic acid (ASA)
  • 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
    Interventions:
    • Drug: Clopidogrel
    • Drug: Acetylsalicylic acid (ASA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
404
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2014)
400
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02217501
Other Study ID Numbers  ICMJE 122013-065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Study results will be posted on clinical.trials.gov and through publications and presentations
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Subhash Banerjee, MD University of Texas Southwestern Medical Center
Study Chair: Subhash Banerjee, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP