Back to results

The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Cilostazol

placebo

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
Neurologically and clinically stable at inclusion
PAD (i.e. ankle-brachial index or ABI <1.0)

Exclusion Criteria:

Patients unable to give informed consent
Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
Modified Rankin Scale >4
Patients with history of dementia requiring institutional care
Known brain tumor
Known anemia (defined as hemoglobin <10.0 g/dL)
Known thrombocytopenia (defined as platelet count below 100,000/cm3)
AST or ALT > 3 x Upper Normal Limit
Calculated creatinine clearance < 30 ml/min according to the Copckroft formula)
Known hemostasis or coagulation disorder
Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF
Revascularization of the lower limb arteries including bypass surgery, endovascular procedures
Symptomatic PAD requiring treatment with cilostazol
Known stenosis of the upper limb arteries that may affect the documentation of ABI
Patients with known hypersensitivity to cilostazol

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cilostazol

placebo

Arm Description

Pletaal® (Cilostazol) 100 mg, bid p.o.

Placebo 1 tablet, bid p.o.

Outcomes

Primary Outcome Measures

The primary endpoint for this study is slowdown of PAD progression based on ABI.

Secondary Outcome Measures

Carotid intima-media thickness

Carotid intima-media thickness. Vascular events, including recurrent stroke, myocardial infarction, unstable angina,other vascular events, and all death. Safety, including major bleeding events, hemorrhagic stroke, any death.

Full Information

NCT ID

NCT01188824

First Posted

August 23, 2010

Last Updated

September 30, 2013

Sponsor

China Medical University Hospital

Collaborators

National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Tri-Service General Hospital, Far Eastern Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, E-DA Hospital, Mackay Memorial Hospital, Cathay General Hospital, En Chu Kong Hospital, Kuang Tien General Hospital, Chung Shan Medical University, Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01188824

Brief Title

The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

Official Title

The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Medical University Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.

Detailed Description

One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4.5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4.5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

801 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cilostazol

Arm Type

Active Comparator

Arm Description

Pletaal® (Cilostazol) 100 mg, bid p.o.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 1 tablet, bid p.o.

Intervention Type

Drug

Intervention Name(s)

Cilostazol

Other Intervention Name(s)

Pletaal®

Intervention Description

100 mg, bid p.o.

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

1 tablet, bid

Primary Outcome Measure Information:

Title

The primary endpoint for this study is slowdown of PAD progression based on ABI.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Carotid intima-media thickness

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed. Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD Neurologically and clinically stable at inclusion PAD (i.e. ankle-brachial index or ABI <1.0) Exclusion Criteria: Patients unable to give informed consent Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others) Modified Rankin Scale >4 Patients with history of dementia requiring institutional care Known brain tumor Known anemia (defined as hemoglobin <10.0 g/dL) Known thrombocytopenia (defined as platelet count below 100,000/cm3) AST or ALT > 3 x Upper Normal Limit Calculated creatinine clearance < 30 ml/min according to the Copckroft formula) Known hemostasis or coagulation disorder Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF Revascularization of the lower limb arteries including bypass surgery, endovascular procedures Symptomatic PAD requiring treatment with cilostazol Known stenosis of the upper limb arteries that may affect the documentation of ABI Patients with known hypersensitivity to cilostazol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chung Y. Hsu, MD. Ph.D.

Organizational Affiliation

China Medical University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

We'll reach out to this number within 24 hrs