Study of Antithrombotic Treatment After Intracerebral Haemorrhage-Antiplatelets: A Randomized Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 500 participants or records.
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