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

This study has been completed.
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: September 30, 2013
Last verified: July 2013

August 23, 2010
September 30, 2013
September 2010
July 2013   (final data collection date for primary outcome measure)
The primary endpoint for this study is slowdown of PAD progression based on ABI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01188824 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)
The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: Cilostazol
    100 mg, bid p.o.
    Other Name: Pletaal®
  • Other: placebo
    1 tablet, bid
    Other Name: placebo
  • Active Comparator: Cilostazol
    Pletaal® (Cilostazol) 100 mg, bid p.o.
    Intervention: Drug: Cilostazol
  • Placebo Comparator: placebo

    Placebo

    1 tablet, bid p.o.

    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
801
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01188824
DMR99-IRB-137
Yes
China Medical University Hospital
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
China Medical University Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP