Cilostazol Following Peripheral Endovascular Procedures

Peripheral Arterial Disease Clinical Trial

— CILO-PER  

Official title:

Multi-center, Randomized Trial Comparing Dual Antiplatelet Therapy With CILOstazol Plus Aspirin Versus Aspirin Alone Following PERipheral Endovascular Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02770274
• Other study ID #: 1316/15-2-16
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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