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

Phase 3

Withdrawn

• Conditions: Peripheral Arterial Disease; Endovascular Procedures
• Interventions: Drug: Aspirin; Drug: Clopidogrel

• Registration Number: NCT02433587
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Status Verified: 2019-10
• Study Start: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-07
• Primary Completion: 2021-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Term	Aspirin	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.
Long Term	Clopidogrel	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.
Short Term	Clopidogrel	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.
Long Term	Aspirin	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.

Primary Outcome Measures

Name	Time	Method
Major Adverse Limb Event Rates	12 months post-intervention	Severe limb ischemia leading to a reintervention or major vascular amputation
Major Adverse Cardiovascular Event Rates	12 months post-intervention	Stroke, Myocardial Infarction, Cardiovascular Death

Secondary Outcome Measures

Name	Time	Method
Quality of Life Outcome	12 Months post-intervention	Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States