Cerebrovascular Accident Clinical Trial
Official title:
EARLY: Prospective, Randomised, National, Multi-centre, Open-label, Blinded Endpoint Study to Compare Aggrenox b.i.d. (200 mg Dipyridamole MR + 25 mg Acetylsalicylic Acid) When Started Within 24 Hours of Stroke Onset on an Acute Stroke Unit, and Aggrenox b.i.d. When Started After a 7-day Therapy With ASA 100 mg Once Daily Outside Off an Acute Stroke Unit, in Symptomatic Ischaemic Stroke Patients Over a Three Months Treatment Period an Exploratory Study
German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke /
transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue
that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented
when compared with sub-acute acetylsalicylic acid (ASA) treatment. However, long term
treatment (started after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to
ASA treatment in preventing recurrent strokes. There is no evidence for ASA to prevent from
neurological progression after stroke during the first 3 months. Results from a cohort study
suggest that starting Aggrenox within 72 hours after stroke predicts clinical improvement in
the National Institute of Health Stroke Scale (NIHSS) at discharge from the hospital.
Dipyridamole suppresses acute inflammatory responses to stroke.
This study is designed to investigate the tolerability and efficacy of a secondary stroke
prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a
stroke unit compared to later initiation after a 7 day ASA treatment and outside off a
stroke unit setting.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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