Effectiveness of Cilostazol on Cognitive Decline in High-risk Elderly PeOple with Ischemic Stroke Compared to Aspirin or ClopidogrEl
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007807
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 2362
1. History of ischemic stroke (more than 3 months ago)
2. At high risk of dementia
(1) Aged 75 years and older,
or
(2) Aged 65-74 years and meeting one of the following conditions:
(i) diabetes mellitus
(ii) severe WMH (Fazekas grade III)
(iii) medial temporal atrophy (Scheltens’ visual grade III or more)
(iv) multiple cerebral microbleeds (=5)
(v) multiple lacunes (>5)
(vi) APOE e4 allele (+)
3. patients signed informed consent
1. Subjects who are illiterate or have neurological deficits to a degree that would interfere with cognitive tests including hearing difficulty, poor cooperation, or severe aphasia.
2. Subjects who have severe disability (e.g., modified Rankin scale > 3)
3. Subjects who have dementia or major psychiatric illness (e.g., schizophrenia, bipolar disorder, major depression) at the time of randomization
4. Subjects who have compelling indication for anticoagulation or dual antiplatelet therapy
5. Subjects who have medical conditions that make it impossible to follow them up for 5 years (e.g., malignancies with life expectance less than 5 years)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from baseline to post-stroke cognitive decline: a decrease of 3 points or more in MMSE-2 SV score and an increase of 1.5 points or more in CDR-SOB score
- Secondary Outcome Measures
Name Time Method 1)Changes in the total score of MMSE-2:SV between baseline and the last assessment 2)Changes in the score of CDR-SOB between baseline and the last assessment 3)Changes in the total score of MoCA between baseline and the last assessment 4)Time from baseline to Incident dementia (DSM-5) 5)Time from baseline to the first recurrent stroke 6)Time from baseline to the composite of post-stroke cognitive decline (primary endpoint) and the first recurrent stroke 7)Time from baseline to the first composite event of stroke, AMI, and all-cause mortality.