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
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
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
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
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
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
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
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