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NCT02433587 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

Official title:
Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02433587
Other study ID # 08-14-29
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date October 2019
Est. completion date July 2023

Study information
Verified date October 2019
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2023
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Aspirin
Patients will take Aspirin 81 mg
• Clopidogrel
Patients will take Clopidogrel 75 mg

Locations
Country Name City State
United States University Hospitals Case Medical Center Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiovascular Event Rates Stroke, Myocardial Infarction, Cardiovascular Death 12 months post-intervention
Primary Major Adverse Limb Event Rates Severe limb ischemia leading to a reintervention or major vascular amputation 12 months post-intervention
Secondary Quality of Life Outcome Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey 12 Months post-intervention
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