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

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00562588

Purpose

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.

Condition	Intervention	Phase
Cerebrovascular Accident	Drug: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg Drug: ASA 100 mg qd	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Dipyridamole TX 3301

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome 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 ]

Enrollment:	548
Study Start Date:	July 2007
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562588

Locations

Germany
9.182.1 Boehringer Ingelheim Investigational Site
Bad Homburg, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	9.182
Study First Received:	July 6, 2007
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00562588 History of Changes
Health Authority:	Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)

Study placed in the following topic categories:

Vasodilator Agents
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Agents
Ischemia
Brain Diseases

Cerebrovascular Disorders
Phosphodiesterase Inhibitors
Aspirin
Brain Ischemia
Platelet Aggregation Inhibitors
Brain Infarction
Infarction
Dipyridamole

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents

Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Brain Ischemia
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Brain Infarction
Dipyridamole

ClinicalTrials.gov processed this record on September 10, 2009