Cilostazol Following Peripheral Endovascular Procedures

NCT02770274 | Unknown Phase 3

• 1 other identifier: 1316/15-2-16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of major adverse cardiovascular and limb events

  1 year

Secondary Outcomes (7)

• Drug-related complications

  1 year

• Clinical improvement

  1-year

• Quality of life assessment

  1 year

• Procedure-related complications

  1 month

• Ankle-Brachial Index (ABI) changes

  6 and 12 months

Study Arms (2)

Group Cilostazol

EXPERIMENTAL

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

Drug: Cilostazol; Drug: Aspirin

Group Aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin

Interventions

Cilostazol DRUG

Dual therapy with Cilostazol 100 mg twice daily

Group Cilostazol

Aspirin DRUG

Monotherapy with aspirin 100 mg once daily

Group Aspirin; Group Cilostazol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead
• University Hospital of Patras: collaborator

Study Sites (2)

Patras Universityu Hospital

Pátrai, Achaia, Greece

RECRUITING

Attikon university General Hospital

Athens, Attica, 15343, Greece

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Cilostazol; Aspirin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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 CHAIR

Central Study Contacts

Stavros Spiliopoulos, MD, PhD, EBIR

CONTACT

+306937403468; stavspiliop@med.uoa.gr

Lazaros Reppas, MD

CONTACT

+306947217995; l.reppas@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

GR (2)