Cilostazol Following Peripheral Endovascular Procedures (CILO-PER)

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Drug: Cilostazol; Drug: Aspirin

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stavros Spiliopoulos, MD, PhD, EBIR; Phone Number: +306937403468; Email: stavspiliop@med.uoa.gr
• Study Contact Backup: Name: Lazaros Reppas, MD; Phone Number: +306947217995; Email: l.reppas@yahoo.com

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece
      • Recruiting
      • Patras Universityu Hospital
      • Contact: Dimitris Karnabatidis, MD, PhD; Phone Number: 219 +302613603; Email: karnaby@med.upatras.gr
      • Contact: Panagiotis Kitrou, MD, PhD; Phone Number: 218 +302613603; Email: panoskitrou@gmail.com
      • Principal Investigator: Dimitris Karnabatidis, MD, PhD
      • Sub-Investigator: Panagiotis Kitrou, MD, PhD
      • Sub-Investigator: Kostantinos Katsanos, MD, PhD
  • Attiki
    • Athens, Attiki, Greece, 15343
      • Recruiting
      • Attikon University General Hospital
      • Contact: Stavros Spiliopoulos, MD, PhD; Phone Number: 1832 +30210581; Email: stavspiliop@med.uoa.gr
      • Contact: Lazaros Reppas, MD; Phone Number: 1844 +3021058; Email: l.reppas@yahoo.com
      • Principal Investigator: Elias Brountzos, MD, PhD
      • Sub-Investigator: Stavros Spiliopoulos, MD, PhD
      • Sub-Investigator: Lazaros Reppas, MD
      • Sub-Investigator: Maria Tsitskari, MD
      • Sub-Investigator: George Geroulakos, MD, PhD
      • Sub-Investigator: Christos Kakkisis, MD, PhD
      • Sub-Investigator: Andreas Lazaris, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite endpoint of major adverse cardiovascular and limb events	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Aspirin; Cilostazol
• Other Study ID Numbers: 1316/15-2-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided