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CILO-PER: Cilostazol Following Peripheral Endovascular Procedures

Sponsor
Attikon Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02770274
Collaborator
University Hospital of Patras (Other)
200
Enrollment
2
Locations
2
Arms
60
Anticipated Duration (Months)
100
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Multi-center, Randomized Trial Comparing Dual Antiplatelet Therapy With CILOstazol Plus Aspirin Versus Aspirin Alone Following PERipheral Endovascular Procedures
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Cilostazol

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

Drug: Cilostazol
Dual therapy with Cilostazol 100 mg twice daily

Drug: Aspirin
Monotherapy with aspirin 100 mg once daily
Active Comparator: Group Aspirin

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

Drug: Aspirin
Monotherapy with aspirin 100 mg once daily

Outcome Measures

Primary Outcome Measures

  1. Composite endpoint of major adverse cardiovascular and limb events [1 year]

Secondary Outcome Measures

  1. Drug-related complications [1 year]

    Major and minor drug-related complications (including bleeding).

  2. Clinical improvement [1-year]

    Clinical improvement of target limb according to Rutherford-Becker classification

  3. Quality of life assessment [1 year]

    Assessment of quality of life changes during follow up period using dedicated questionnaire

  4. Procedure-related complications [1 month]

    Minor and major procedure-related complications

  5. Ankle-Brachial Index (ABI) changes [6 and 12 months]

    Ankle-Brachial Index (ABI) measurements during follow up

  6. Blood cholesterol level monitoring [6 and 12 months]

    Blood test to monitor cholesterol levels during follow up

  7. Blood glucose level monitoring [6-12 months]

    Blood test to monitor glucose levels during follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Patras Universityu Hospital Patras Achaia Greece
2 Attikon university General Hospital Athens Attiki Greece 15343

Sponsors and Collaborators

  • Attikon Hospital
  • University Hospital of Patras

Investigators

  • Study Chair: Elias Brountzos, MD, PhD, EBIR, 2nd Department of Radiology, Interventional Radiology Unit, National and Kapodestrian University of Athens, Attikon University General Hospital, Athens, Greece.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stavros Spiliopoulos, Assistant Professor of Radiology, Attikon Hospital
ClinicalTrials.gov Identifier:
NCT02770274
Other Study ID Numbers:
  • 1316/15-2-16
First Posted:
May 12, 2016
Last Update Posted:
Jan 12, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aspirin
Cilostazol

Study Results

No Results Posted as of Jan 12, 2021