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.
- Aggrenox (Aggrenox)Drug
Intervention Desc: Aspirin and Extended-Release Dipyridamole decreases the risk of stroke in patients who have had a stroke or transient ischemic attack (known as a 'TIA' or 'mini-stroke') by helping to prevent dangerous blood clots from forming. Generic aspirin-dipyridamole combinations are not available.
- Aspirin Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
- Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) Drug
- ASA 100 mg qd Drug
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients were randomly assigned to receive 25 mg aspirin plus 200 mg extended-release dipyridamole open-label twice daily or 100 mg aspirin monotherapy open-label once daily for 7 days. Patients had a baseline NIHSS and mRS. Patients were followed up in 90 days with a telephone mRS.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Telephone modified Rankin Scale|
|Secondary||•NIHSS,mRS (assessed by investigator)Time to first relevant event (vascular or non vascular death,non fatal stroke,non fatal myocardial infarction,bleeding complication), centralised,blinded assessment;MRI,centralised, blinded assessment;Laboratory .|
|Primary||Telephone Modified Rankin Scale (Centralised, Blinded Assessment)||90 days||No|
|Secondary||Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)||Baseline and 90 days|
|Secondary||Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)||90 days||Yes|
|Secondary||Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8||8 days||No|
|Secondary||Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8||Baseline and 8 days||No|
|Secondary||Change of Special Biochemical Laboratory Value- CRP||8 days||No|
|Secondary||Change of Special Biochemical Laboratory Value- MMP-9||8 days||No|
|Secondary||Change of Special Biochemical Laboratory Value - MCP-1||8 days||No|
|Secondary||Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8||Baseline and day 8||No|
|Secondary||Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.||Baseline and day 90||No|
|Secondary||Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8||Baseline and day 8||No|
|Secondary||Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90||Baseline and day 90||No|