EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebrovascular Accident
Intervention: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) (Drug); ASA 100 mg qd (Drug)
Phase: Phase 4
Sponsored by: Boehringer Ingelheim
Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
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.
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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Primary outcome: Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)
Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8
Change of Special Biochemical Laboratory Value- CRP
Change of Special Biochemical Laboratory Value- MMP-9
Change of Special Biochemical Laboratory Value - MCP-1
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- Actual Modified Rankin Scale (mRS) (at baseline) is worse than retrospective mRS
- A contraindication for stroke lysis is given
- Patients are able to give (at least oral) informed consent and to swallow either
- 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)
Locations and Contacts
9.182.1 Boehringer Ingelheim Investigational Site, Bad Homburg, Germany
Starting date: July 2007
Last updated: January 31, 2014