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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
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    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
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    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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