Cilostazol Following Peripheral Endovascular Procedures | NCT02770274

Studies
Cilostazol Following Peripheral Endovascular Procedures

NCT02770274

Sponsor

Attikon Hospital

Status

Unknown status

Last Update Posted

Jan 12, 2021Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Peripheral Arterial Disease

Interventions

Cilostazol
Aspirin

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

May 10, 2016

First Submission Date that Met QC Criteria

May 11, 2016

First Posted Date

May 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2021

Last Update Posted Date

Jan 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stavros Spiliopoulos, Assistant Professor of Radiology, Attikon HospitalPrincipal Investigator

Lead Sponsor

Attikon HospitalOTHER

Collaborators

Name	Class
University Hospital of Patras	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cilostazol	Drug	Dual therapy with Cilostazol 100 mg twice daily	Group Cilostazol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stavros Spiliopoulos, MD, PhD, EBIR	Contact	+306937403468		stavspiliop@med.uoa.gr
Lazaros Reppas, MD	Contact	+306947217995		l.reppas@yahoo.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Patras Universityu Hospital	Recruiting	Pátrai	Achaia		Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077407	Cilostazol
D001241	Aspirin

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided