Trial Number

028-20

Condition

Stroke

Participant Age Range

50 years and older

Participant Gender

Any

Enrolling Participants

Yes

Overview

STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS

While the benefits of statins in reducing major adverse cardiac and cerebrovascular events (MACCE) in patients with ischemic stroke are well established, their benefits and risks in patients at high risk for intracerebral hemorrhage (ICH), particularly those with lobar ICH who are at high risk for ICH recurrence, are not clear. Statin use has been associated with a slight increase in the incidence of ICH, the presence and number of asymptomatic microbleeds on gradient-echo MRI, and the risk of ICH recurrence, particularly in patients with lobar ICH who have APOE ε2 and ε4 genotypes. On the other hand, discontinuation of statins might increase the risk of mortality due to MACCE, obviate statins’ effects on promoting neurological recovery after ICH, or predispose to cognitive decline due to accumulation of microbleeds. There are no prospective or randomized data on the effects of continuation vs. discontinuation of statins after ICH regarding the competing risks of ICH recurrence and incidence of MACCE, long-term functional and cognitive outcomes, and neurological recovery. This gap in knowledge creates uncertainty regarding how best to manage ICH patients and clinical equipoise as to whether statins should be used in patients at high risk for recurrent ICH. This study represents a multi-center, pragmatic, prospective, randomized, open-label, Phase III clinical trial in patients with lobar ICH taking statins to determine whether continuation or discontinuation of these drugs is the best strategy.

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