FYI.
Stroke and High-risk TIAs Outcomes with Reduction of Treatment duration when treatment initiated in Emergency Rooms. (SHORTER-Study)
Abstract
Background:
Following
TIA and minor stroke, the risk of recurrent stroke can be significantly
reduced with short duration dual antiplatelet therapy (DAPT). We wish
to investigate if 10 days of DAPT is as effective as 21 days treatment.
Study design:
This
is an open-label, randomized, parallel-group study comparing whether 10
days of DAPT treatment (ASA+Clopidogrel) is non-inferior to 21-day of
DAPT. in patients with minor ischemic stroke (AIS) or high-risk
transient ischemic attack (TIA). In both groups DAPT is started within
24 hours of symptom onset.
This study is being conducted in approximately 15 study sites in the Kingdom of Saudi Arabia. The planned sample size if 1932.
Outcomes:
Noninferiority
of 10 days compared to 21 days of DAPT in the prevention of the
composite endpoint of stroke and death at 90 days in AIS/TIA patients.
The primary safety outcome is major intracranial and systemic
hemorrhage.
Study period:
Enrolment started in the second quarter of 2023, and the completion of the study is expected in the fourth quarter of 2025.
Discussion:
The
trial is expected to show that 10 days of DAPT is non-inferior for the
prevention of early recurrence of vascular events in patients with
high-risk TIAs and minor strokes.
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