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 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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg
  • Aggrenox (25 mg ASA+200 mg Dipyridamole), 2 capsules p.o. per day
• Drug: ASA 100 mg qd
  • ASA 100 mg p.o. once daily for 7 days; Aggrenox (25 mg ASA+200 mg Dipyridamole), 2 capsules p.o. per day from day 8-90

Primary Measures

• Telephone modified Rankin Scale (centralised, blinded assessment)
  • Time Frame: 90 days
    

Secondary Measures

• 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
  • Time Frame: 90 days
    

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. NIHSS between 5 and 20 (at pre-screening and screening). Actual 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 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Overall Contact: Boehringer Ingelheim Study Coordinator  clintriage@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00562588

Study ID Number: 9.182

ClinicalTrials.gov Identifier: NCT00562588

Health Authority: Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)