Effectiveness of Cilostazol on Cognitive Decline in High-risk Elderly PeOple with Ischemic Stroke Compared to Aspirin or ClopidogrEl

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007807

Enrollment

2362

Registered

2022-10-14

Start date

2022-11-02

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Intervention: cilostazol 200mg, once daily, per oral or per nasogastric tube, until the end of data collection time (60 months at the maximum) Control: aspirin 100~300mg or clopidogrel 75mg, on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Korea, Republic of

Contacts

Public ContactSEUNG HEE LEE

Seoul National University Bundang Hospital

butteri1004@gmail.com+82-31-787-8307

Outcome results