On behalf of the MR ASAP Investigators
A pooled analysis of randomised trials has suggested that administration of glyceryl trinitrate (GTN) via a transdermal patch in the first hours after stroke onset increases the chance of a favourable outcome, but this was not confirmed in a subsequent trial. We assessed the effect of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days in patients with presumed acute stroke.
We performed a phase 3, multicentre, prospective, randomised, open-label, blinded end point (PROBE) trial in the Netherlands. Adults with presumed acute stroke within 3 hours of symptom onset, a face-arm-speech-time score of 2 or 3, and a systolic blood pressure ≥140 mmHg were randomised (1:1) to receive transdermal GTN (5 mg/day for 24 hours) plus standard care or to standard care alone. GTN was started in the prehospital setting and continued in the hospital. The trial used a deferred consent procedure. The primary outcome was functional outcome assessed with the modified Rankin Scale (mRS) at 90 days, analysed with ordinal logistic regression. Secondary outcomes included mortality and poor outcome (mRS score 3 to 6) at 90 days. Predefined subgroup analyses included stroke type and treatment with intravenous thrombolysis or endovascular thrombectomy. The target sample was 1400 patients. The trial is registered as ISRCTN99503308.
In June 2021, the trial was terminated because of futility after the inclusion of 326 patients.
Final results will be presented at the Conference.
ISRCTN99503308