Clinical trial NCT02770274: Cilostazol Following Peripheral Endovascular Procedures
Official title: Multi-center, Randomized Trial Comparing Dual Antiplatelet Therapy With CILOstazol Plus Aspirin Versus Aspirin Alone Following PERipheral Endovascular Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Arterial Disease
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of Patras
First posted: 2016-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint of major adverse cardiovascular and limb events
timeFrame: 1 year
Secondary outcomes:
measure: Drug-related complications
timeFrame: 1 year
measure: Clinical improvement
timeFrame: 1-year
measure: Quality of life assessment
timeFrame: 1 year
measure: Procedure-related complications
timeFrame: 1 month
measure: Ankle-Brachial Index (ABI) changes
timeFrame: 6 and 12 months
measure: Blood cholesterol level monitoring
timeFrame: 6 and 12 months
measure: Blood glucose level monitoring
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Patras Universityu Hospital
state: Achaia
city: Athens
country: Greece
facility: Attikon university General Hospital
state: Attiki
Study officials:
affiliation: 2nd Department of Radiology, Interventional Radiology Unit, National and Kapodestrian University of Athens, Attikon University General Hospital, Athens, Greece.
name: Elias Brountzos, MD, PhD, EBIR
role: STUDY_CHAIR
References: