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Published on: June 18, 2021
Design and Rationale for a Cognitive Outcome Substudy in Ischemic Stroke Patients with High Risk of Cerebral
Kyung-Ho Yu1, Keun-Sik Hong2, Mi-Sun Oh1
1Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Chunchon, Republic of Korea.
Insights
This study investigates if cilostazol and probucol can prevent cognitive decline in stroke patients. Researchers aim to preserve cognitive function and reduce dementia risk after ischemic stroke.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Gerontology
Background:
- Cognitive impairment and dementia are frequent, serious complications following stroke.
- These conditions increase mortality and recurrent stroke risks.
- Effective strategies for preventing post-stroke dementia remain unestablished.
Purpose of the Study:
- To evaluate the impact of cilostazol and/or probucol on cognitive function in ischemic stroke patients.
- To assess the potential of these agents in reducing cognitive decline.
- To explore novel therapeutic approaches for preserving cognitive health post-stroke.
Main Methods:
- The PICASSO-COG substudy utilizes data from the PICASSO trial.
- Cognitive function is measured using the Korean mini-mental state examination and Montreal Cognitive Assessment at multiple time points up to 49 months.
- Statistical analysis employs a restricted maximum likelihood-based mixed effects model for repeated measurements.
Main Results:
- Primary outcome: change in mini-mental status examination score compared between treatment groups.
- Analysis includes a modified intention-to-treat population.
- The model accounts for within-subject correlations and varying measurement frequencies.
Conclusions:
- PICASSO-COG is a pioneering study examining antiplatelet and lipid-lowering therapies' effects on cognition.
- It assesses cilostazol and probucol in patients with recent ischemic lesions and prior cerebral microbleeds.
- Findings will inform strategies for cognitive preservation in high-risk stroke populations.
Goal:
Cognitive impairment and dementia are common disabilities after stroke and are associated with increased risks of mortality and recurrent stroke. The prevention of dementia and preserving cognitive function are also important in stroke patients, but its strategy is not established yet. This PICASSO-COG (PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage for reducing COGnitive decline) substudy aims to assess the effects of cilostazol and/or probucol on cognitive function.
Materials And Methods:
The substudy aims to assess the reduction in cognitive decline of patients treated with cilostazol and/or probucol in the PICASSO trial. Patients will be assessed using the Korean version of mini-mental state examination and Montreal Cognitive Assessment at 4, 7, 10, 13, 25, 37, and 49 months after randomization. The primary outcome is the change in mini-mental status examination score, compared between treatment groups, with a modified intention-to-treat population using a restricted maximum likelihood-based mixed effects model repeat measurement. This will allow a within-subject correlation due to repeated cognitive tests as well as a different number of measurements among subjects at baseline and each follow-up period.
Conclusion:
PICASSO-COG is a novel study for assessing the effect on cognitive function of different antiplatelet regimens and the addition of a nonstatin lipid-lowering agent to the current standard statin therapy in patients who have a recent ischemic lesion and prior intracerebral macro- or microbleeds.

