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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01188824
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : October 7, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Cilostazol Other: placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 801 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
Study Start Date : September 2010
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Cilostazol
Pletaal® (Cilostazol) 100 mg, bid p.o.
Drug: Cilostazol
100 mg, bid p.o.
Other Name: Pletaal®
Placebo Comparator: placebo


1 tablet, bid p.o.

Other: placebo
1 tablet, bid

Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint for this study is slowdown of PAD progression based on ABI. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Carotid intima-media thickness [ Time Frame: 2 years ]
    1. Carotid intima-media thickness.
    2. Vascular events, including recurrent stroke, myocardial infarction, unstable angina,other vascular events, and all death.
    3. Safety, including major bleeding events, hemorrhagic stroke, any death.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT01188824

Sponsors and Collaborators
China Medical University Hospital
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
Principal Investigator: Chung Y. Hsu, MD. Ph.D. China Medical University Hospital
More Information

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01188824     History of Changes
Other Study ID Numbers: DMR99-IRB-137
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Cerebral Infarction
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Arterial Occlusive Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents