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

Tracking Information

First Received Date ^ICMJE

July 6, 2007

Last Updated Date

March 5, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Telephone modified Rankin Scale (centralised, blinded assessment)

Change History

Complete list of historical versions of study NCT00562588 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cerebrovascular Accident

Intervention ^ICMJE

Drug: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg
Drug: ASA 100 mg qd

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

548

Completion Date

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00562588

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

9.182

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP