EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA

Completed

Phase 4 Results

Trial Description

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.

Conditions

Interventions

  • 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
    Other Names: Aspirin at bedtime
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) Drug
  • ASA 100 mg qd Drug

Trial Design

  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

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

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