EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
Condition: Cerebrovascular Accident
MeSH terms: Stroke; Ischemic Stroke
Intervention: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg); ASA 100 mg qd
Intervention MeSH terms: Dipyridamole; Aspirin, Dipyridamole Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 551.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

        -Clinical diagnosis of ischaemic stroke causing a measurable neurological deficit defined
        as impairment of language, motor function, cognition and/or gaze, vision or neglect.
        Symptoms must be distinguishable from an episode of generalised ischaemia (i.e. syncope),
        seizure, or migraine disorder.

        Main inclusion criteria:

          -  Patients at risk of stroke who have had transient ischaemia of the brain or completed
             ischaemic stroke due to thrombosis

          -  Symptoms of ischaemic attack began less than 24 hours prior to study medication start,
             are to be present for at least 30 minutes and have not significantly improved before
             start of treatment

          -  Patients are eligible for platelet inhibiting treatment

          -  National Institute of Health Stroke Scale (NIHSS) between 5 and 20 (at pre-screening
             and screening)

          -  Actual Modified Rankin Scale (mRS) (at baseline) is worse than retrospective mRS
             (before stroke)

          -  A contraindication for stroke lysis is given

          -  Patients are able to give (at least oral) informed consent and to swallow either
             medication

        Exclusion Criteria:

          -  Hypersensitivity to any of the components of the product or salicylates.

          -  Patients with active gastric or duodenal ulcers or with bleeding disorders.

          -  Pregnancy during the third trimester.

          -  Lysis therapy.

          -  A platelet inhibiting therapy with Acetylsalicylic Acid (ASA) doses of more than 100
             mg per day, or with clopidogrel of any dose has been planned or started.

          -  Time of onset of stroke symptoms is unknown (when a stroke happened during
             night-/sleeping time, bedtime is assumed as time of onset)