Design and Rationale for a Cognitive Outcome Substudy in Ischemic Stroke Patients with High Risk of Cerebral Hemorrhage.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Chunchon, Republic of Korea.
Kyung-Ho
KH
Yu
Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Keun-Sik
KS
Hong
Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Chunchon, Republic of Korea.
Mi-Sun
MS
Oh
Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea.
Juneyoung
J
Lee
Clinical Trial Center, Asan Medical Center, Seoul, Republic of Korea.
Ji Sung
JS
Lee
Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: sukwon@amc.seoul.kr.
Sun U
SU
Kwon
D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D002545:Brain Ischemia / Q000150:complications; D002543:Cerebral Hemorrhage / Q000150:complications* / Q000188:drug therapy; D000077407:Cilostazol; D003072:Cognition Disorders / Q000209:etiology* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D007391:International Cooperation; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D009483:Neuropsychological Tests; D011341:Probucol / Q000627:therapeutic use; D020521:Stroke / Q000150:complications* / Q000188:drug therapy / Q000209:etiology; D013777:Tetrazoles / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000924:Anticholesteremic Agents; D005343:Fibrinolytic Agents; D013777:Tetrazoles; D000077407:Cilostazol; D011341:Probucol
Cognitive impairment; cerebral infarction; cilostazol; clinical trial; intracerebral hemorrhage; microbleeds; probucol; vascular dementia