A Phase 4 interventional study of Cilostazol and placebo in Ischemic Stroke, sponsored by China Medical University Hospital. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-10-07.
Sponsored by China Medical University Hospital · Phase 4, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 801 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pletaal® (Cilostazol) 100 mg, bid p.o.
Drug: Cilostazol
Placebo 1 tablet, bid p.o.
Other: placebo
100 mg, bid p.o.
Also known as: Pletaal®
1 tablet, bid
The primary endpoint for this study is slowdown of PAD progression based on ABI.
Time frame: 2 years
Carotid intima-media thickness
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.
Time frame: 2 years
No study locations are listed for this record.
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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China Medical University Hospital