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Cilostazol Following Peripheral Endovascular Procedures (CILO-PER)

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ClinicalTrials.gov Identifier: NCT02770274
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
University Hospital of Patras
Information provided by (Responsible Party):
Stavros Spiliopoulos, Attikon Hospital

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
Peripheral Arterial Disease Drug: Cilostazol Drug: Aspirin 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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Composite endpoint of major adverse cardiovascular and limb events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Drug-related complications [ Time Frame: 1 year ]
    Major and minor drug-related complications (including bleeding).

  2. Clinical improvement [ Time Frame: 1-year ]
    Clinical improvement of target limb according to Rutherford-Becker classification

  3. Quality of life assessment [ Time Frame: 1 year ]
    Assessment of quality of life changes during follow up period using dedicated questionnaire

  4. Procedure-related complications [ Time Frame: 1 month ]
    Minor and major procedure-related complications

  5. Ankle-Brachial Index (ABI) changes [ Time Frame: 6 and 12 months ]
    Ankle-Brachial Index (ABI) measurements during follow up

  6. Blood cholesterol level monitoring [ Time Frame: 6 and 12 months ]
    Blood test to monitor cholesterol levels during follow up

  7. Blood glucose level monitoring [ Time Frame: 6-12 months ]
    Blood test to monitor glucose levels during follow up



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770274


Contacts
Contact: Stavros Spiliopoulos, MD, PhD, EBIR +306937403468 stavspiliop@med.uoa.gr
Contact: Lazaros Reppas, MD +306947217995 l.reppas@yahoo.com

Locations
Greece
Patras Universityu Hospital Recruiting
Patras, Achaia, Greece
Contact: Dimitris Karnabatidis, MD, PhD    +302613603 ext 219    karnaby@med.upatras.gr   
Contact: Panagiotis Kitrou, MD, PhD    +302613603 ext 218    panoskitrou@gmail.com   
Principal Investigator: Dimitris Karnabatidis, MD, PhD         
Sub-Investigator: Panagiotis Kitrou, MD, PhD         
Sub-Investigator: Kostantinos Katsanos, MD, PhD         
Attikon university General Hospital Recruiting
Athens, Attiki, Greece, 15343
Contact: Stavros Spiliopoulos, MD, PhD    +30210581 ext 1832    stavspiliop@med.uoa.gr   
Contact: Lazaros Reppas, MD    +3021058 ext 1844    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         
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.

Responsible Party: Stavros Spiliopoulos, Assistant Professor of Radiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT02770274     History of Changes
Other Study ID Numbers: 1316/15-2-16
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents