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Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02433587
Recruitment Status : Withdrawn (Never recruited any patients.)
First Posted : May 5, 2015
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Vikram S. Kashyap, M.D., University Hospitals Cleveland Medical Center

Brief Summary:
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Endovascular Procedures Drug: Aspirin Drug: Clopidogrel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short Term
The short term group will continue Aspirin 81mg and Clopidogrel 75mg for 1 month after the intervention. After that, they will continue Aspirin 81mg only.
Drug: Aspirin
Patients will take Aspirin 81 mg
Other Name: Acetylsalicylic acid (ASA)

Drug: Clopidogrel
Patients will take Clopidogrel 75 mg
Other Name: Plavix

Experimental: Long Term
The long term group will continue Aspirin 81mg and Clopidogrel 75mg for 6 months after the intervention. After this time, they will continue on Aspirin 81mg only.
Drug: Aspirin
Patients will take Aspirin 81 mg
Other Name: Acetylsalicylic acid (ASA)

Drug: Clopidogrel
Patients will take Clopidogrel 75 mg
Other Name: Plavix




Primary Outcome Measures :
  1. Major Adverse Cardiovascular Event Rates [ Time Frame: 12 months post-intervention ]
    Stroke, Myocardial Infarction, Cardiovascular Death

  2. Major Adverse Limb Event Rates [ Time Frame: 12 months post-intervention ]
    Severe limb ischemia leading to a reintervention or major vascular amputation


Secondary Outcome Measures :
  1. Quality of Life Outcome [ Time Frame: 12 Months post-intervention ]
    Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide signed informed consent before initiation of any study related procedures
  2. Be at least 18 years of age
  3. Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
  4. At least 1 vessel run-off in segment distal to the intervention
  5. Rutherford Classification 2-5 that is unresponsive to medical therapy

Exclusion Criteria:

  1. Acute limb ischemia
  2. Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
  3. Patient undergoing atherectomy procedure
  4. Intervention includes deployment of drug eluted stent
  5. Critical limb ischemia (Rutherford Classification 6)
  6. Thrombocytopenia: Platelet count <50k
  7. Liver disease (Childs-Pugh B or C)
  8. Existing need for on going clopidogrel therapy
  9. Proton Pump Inhibitor Use (If unable to be switched)
  10. Need for therapeutic anticoagulation
  11. Known hypercoagulable disorder
  12. Allergy or contraindication to aspirin or clopidogrel
  13. Pregnancy
  14. Patients enrolled in another investigational drug or device study within the past 30 days

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): NCT02433587


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Responsible Party: Vikram S. Kashyap, M.D., Chief, Division of Vascular Surgery & Endovascular Therapy, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02433587    
Other Study ID Numbers: 08-14-29
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents