Cilostazol Following Peripheral Endovascular Procedures

Phase 3

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Cilostazol; Drug: Aspirin

• Registration Number: NCT02770274
• Lead Sponsor: Attikon Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Study Start: 2016-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Cilostazol	Aspirin	Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months.
Group Cilostazol	Cilostazol	Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months.
Group Aspirin	Aspirin	Patients receiving monotherapy with aspirin 100mg once daily for 12 months.

Primary Outcome Measures

Name	Time	Method
Composite endpoint of major adverse cardiovascular and limb events	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Patras Universityu Hospital; 🇬🇷 Patras, Achaia, Greece

Attikon university General Hospital; 🇬🇷 Athens, Attiki, Greece