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Cilostazol Following Peripheral Endovascular Procedures (CILO-PER)

A

Attikon University Hospital

Status and phase

Unknown
Phase 3

Conditions

Peripheral Arterial Disease

Treatments

Drug: Cilostazol
Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT02770274
1316/15-2-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Group Cilostazol
Experimental group
Description:
Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months.
Treatment:
Drug: Aspirin
Drug: Cilostazol
Group Aspirin
Active Comparator group
Description:
Patients receiving monotherapy with aspirin 100mg once daily for 12 months.
Treatment:
Drug: Aspirin

Trial contacts and locations

2

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Central trial contact

Stavros Spiliopoulos, MD, PhD, EBIR; Lazaros Reppas, MD

Data sourced from clinicaltrials.gov

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