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

NCT ID: NCT01188824

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cilostazol

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

Group Type ACTIVE_COMPARATOR

Cilostazol

Intervention Type DRUG

100 mg, bid p.o.

placebo

Placebo

1 tablet, bid p.o.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

1 tablet, bid

Interventions

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Cilostazol

100 mg, bid p.o.

Intervention Type DRUG

placebo

1 tablet, bid

Intervention Type OTHER

Other Intervention Names

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Pletaal®

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role collaborator

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role collaborator

Changhua Christian Hospital

OTHER

Sponsor Role collaborator

Chi Mei Medical Hospital

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role collaborator

E-DA Hospital

OTHER

Sponsor Role collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role collaborator

Cathay General Hospital

OTHER

Sponsor Role collaborator

En Chu Kong Hospital

OTHER

Sponsor Role collaborator

Kuang Tien General Hospital

OTHER

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chung Y. Hsu, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Countries

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Taiwan

Other Identifiers

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DMR99-IRB-137

Identifier Type: -

Identifier Source: org_study_id