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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02433587

Enrollment

Registered

2015-05-05

Start date

2019-10-31

Completion date

2023-07-31

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovascular Procedures, Peripheral Arterial Disease

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.

Interventions

DRUGAspirin

Patients will take Aspirin 81 mg

DRUGClopidogrel

Patients will take Clopidogrel 75 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026