Cilostazol Following Peripheral Endovascular Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group Cilostazol

Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months.

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Dual therapy with Cilostazol 100 mg twice daily

Aspirin

Intervention Type DRUG

Monotherapy with aspirin 100 mg once daily

Group Aspirin

Patients receiving monotherapy with aspirin 100mg once daily for 12 months.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Monotherapy with aspirin 100 mg once daily

Interventions

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Cilostazol

Dual therapy with Cilostazol 100 mg twice daily

Intervention Type DRUG

Aspirin

Monotherapy with aspirin 100 mg once daily

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Stavros Spiliopoulos

Assistant Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elias Brountzos, MD, PhD, EBIR

Role: STUDY_CHAIR

2nd Department of Radiology, Interventional Radiology Unit, National and Kapodestrian University of Athens, Attikon University General Hospital, Athens, Greece.