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

This study is ongoing, but not recruiting participants.
Sponsor:
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
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01188824
First received: August 23, 2010
Last updated: February 5, 2013
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Ischemic Stroke
 Drug: Cilostazol
Other: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

Resource links provided by NLM:

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

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • The primary endpoint for this study is slowdown of PAD progression based on ABI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid intima-media thickness [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cilostazol
Pletaal® (Cilostazol) 100 mg, bid p.o.
 Drug: Cilostazol
100 mg, bid p.o.
Other Name: Pletaal®
Placebo Comparator: placebo

Placebo

1 tablet, bid p.o.

 Other: placebo
1 tablet, bid
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Chung Y. Hsu, MD. Ph.D. China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01188824     History of Changes
Other Study ID Numbers: DMR99-IRB-137
Study First Received: August 23, 2010
Last Updated: February 5, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013