EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Aspirin, Dipyridamole Drug Combination Dipyridamole