Study of Antithrombotic Treatment After Intracerebral Haemorrhage-Antiplatelets: A Randomized Trial

BACKGROUND: Patients surviving spontaneous intracerebral hemorrhage (ICH) who have indications for antithrombotic treatment face increased risks of both hemorrhagic and ischemic events. The aim of STATICH (Study of Antithrombotic Treatment After Intracerebral Haemorrhage) was to assess the safety and efficacy of long-term antithrombotic treatment after ICH.

METHODS: STATICH Antiplatelets (EudraCT 2014-002636-13; Unique identifier: NCT03186729) was a randomized, multicenter, open, blinded end point parallel-group trial, including adults with an indication for antiplatelet treatment to either start or avoid antiplatelet treatment. The target sample size was 500 participants. Patients were allocated 1:1 by a Web-based randomization system and followed for a minimum of 2 years. Outcome assessments were done by personnel blinded to treatment. Participants were not blinded. The primary safety outcome was recurrent symptomatic ICH.

RESULTS: The trial was stopped early due to slow recruitment. Sixty-nine patients were included between August 2018 and December 2022: 34 were randomized to start antiplatelet treatment, and 35 were randomized to avoid antiplatelet treatment. No patients were excluded from analyses. The median age was 75 (Q1-Q3, 66-80) years, and 43 (75%) had previous ischemic stroke or transient ischemic attack. Five patients in the start antiplatelet treatment group (15% [95% CI, 6%-31%]), and 1 in the avoid group (3% [95% CI, 0%-18%]) experienced recurrent ICH, while 3 (9% [95% CI, 3%-24%]) and 7 (20% [95% CI, 10%-37%]), respectively, experienced a major ischemic event. A total of 88 serious adverse events and no suspected unexpected serious adverse reactions were registered.

CONCLUSIONS: There were numerically more recurrent ICHs and fewer ischemic events in patients starting antiplatelet treatment after ICH compared with those avoiding antiplatelet treatment. The slow recruitment might be due to clinicians being certain of the best treatment strategy or patients being too frail to participate. STATICH will contribute to a planned collaborative individual patient-data meta-analysis to resolve this dilemma.