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

NCT00562588 | Completed Phase 4 Results

• 1 other identifier: 9.182
• Study Type: interventional
• Target: 551
• Locations: 1 country
• Sites: 1

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 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

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• Telephone Modified Rankin Scale (Centralised, Blinded Assessment)

  The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)

  90 days

Secondary Outcomes (11)

• Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)

  Baseline and 90 days

• Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)

  90 days

• Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8

  8 days

• Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8

  Baseline and 8 days

• Change of Special Biochemical Laboratory Value- CRP

  8 days

Interventions

Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) DRUG

ASA 100 mg qd DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

9.182.1 Boehringer Ingelheim Investigational Site

Bad Homburg, Germany

Location

Related Publications (1)

• Dengler R, Diener HC, Schwartz A, Grond M, Schumacher H, Machnig T, Eschenfelder CC, Leonard J, Weissenborn K, Kastrup A, Haberl R; EARLY Investigators. Early treatment with aspirin plus extended-release dipyridamole for transient ischaemic attack or ischaemic stroke within 24 h of symptom onset (EARLY trial): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 Feb;9(2):159-66. doi: 10.1016/S1474-4422(09)70361-8. Epub 2010 Jan 7.

  PMID: 20060783 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: November 22, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Last Updated: March 19, 2014
• Results First Posted: March 11, 2010

Record last verified: 2014-01

Locations

DE (1)