Cilostazol Following Peripheral Endovascular Procedures

Study Overview
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Brief Summary
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To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease.

Detailed Description
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This is a multi-center, randomized, single-blinded, phase III, controlled trial investigating the safety and effectiveness of dual antiplatelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral, infrainguinal angioplasty or stenting or both for the management of peripheral arterial disease (intermittent claudication or critical limb ischemia). The study will include in total 200 patients randomized on a 1:1 basis to receive either dual antiplatelet therapy for 6 months cilostazol 100 mg once daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily for 12 months. The study's primary endpoint will be the composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, major amputation, target limb open surgical or endovascular revascularization). Additional therapy with clopidogrel 75mg daily will be added in either group for one month in case of stent placement. Secondary endpoints will include quality of life assessment using dedicated questionnaires, drug- and procedure-related complication rates, target-limb revascularization rates, clinical improvement (ABI and Rutherford-Becker classification changes). Clinical follow up will be performed at 1, 6 and 12 months and will include physical examination, ABI measurements, Rutherford-Becker classification. Maximum follow up period will be 2 years after the index procedure.

Official Title
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Multi-center, Randomized Trial Comparing Dual Antiplatelet Therapy With CILOstazol Plus Aspirin Versus Aspirin Alone Following PERipheral Endovascular Procedures

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled infrainguinal (femoropopliteal or infrapopliteal or both) angioplasty and/or stenting. Surgical or endovascular treatment of Inflow iliac artery significant stenosis if deemed necessary. Symptomatic severe intermittent claudication (Rutherford-Becker 3) or critical limb ischemia (Rutherford-Becker 4-6). Informed consent signed Exclusion Criteria: Any contraindication to aspirin or cilostazol intake No pedal arch outflow Sole iliac artery treatment Standard contraindications to angioplasty Acute or sub-acute limb ischemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Cilostazol<br>Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months. | Drug: Cilostazol<br>* Dual therapy with Cilostazol 100 mg twice daily<br>Drug: Aspirin<br>* Monotherapy with aspirin 100 mg once daily<br>|
| Active Comparator: Group Aspirin<br>Patients receiving monotherapy with aspirin 100mg once daily for 12 months. | Drug: Aspirin<br>* Monotherapy with aspirin 100 mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of major adverse cardiovascular and limb events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-related complications | Major and minor drug-related complications (including bleeding). | 1 year | 
| Clinical improvement | Clinical improvement of target limb according to Rutherford-Becker classification | 1-year | 
| Quality of life assessment | Assessment of quality of life changes during follow up period using dedicated questionnaire | 1 year | 
| Procedure-related complications | Minor and major procedure-related complications | 1 month | 
| Ankle-Brachial Index (ABI) changes | Ankle-Brachial Index (ABI) measurements during follow up | 6 and 12 months | 
| Blood cholesterol level monitoring | Blood test to monitor cholesterol levels during follow up | 6 and 12 months | 
| Blood glucose level monitoring | Blood test to monitor glucose levels during follow up | 6-12 months |