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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02770274
Other study ID # 1316/15-2-16
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 2016
Est. completion date December 2021

Study information

Verified date January 2021
Source Attikon Hospital
Contact Stavros Spiliopoulos, MD, PhD, EBIR
Phone +306937403468
Email stavspiliop@med.uoa.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Drug:
Cilostazol
Dual therapy with Cilostazol 100 mg twice daily
Aspirin
Monotherapy with aspirin 100 mg once daily

Locations

Country Name City State
Greece Attikon university General Hospital Athens Attiki
Greece Patras Universityu Hospital Patras Achaia

Sponsors (2)

Lead Sponsor Collaborator
Attikon Hospital University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

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