Back to resultsEARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg)
ASA 100 mg qd
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident
Eligibility 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
- 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
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 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)
Sites / Locations
- 9.182.1 Boehringer Ingelheim Investigational Site
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)
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
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)
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)
Change of Special Biochemical Laboratory Value- CRP
Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Change of Special Biochemical Laboratory Value- MMP-9
Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Change of Special Biochemical Laboratory Value - MCP-1
Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8
MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.
MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8
MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90
MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00562588
Brief Title
EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Enrollment
551 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg)
Intervention Type
Drug
Intervention Name(s)
ASA 100 mg qd
Primary Outcome Measure Information:
Title
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)
Description
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)
Time Frame
Baseline and 90 days
Title
Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)
Time Frame
90 days
Title
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
Description
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)
Time Frame
8 days
Title
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8
Description
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)
Time Frame
Baseline and 8 days
Title
Change of Special Biochemical Laboratory Value- CRP
Description
Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Time Frame
8 days
Title
Change of Special Biochemical Laboratory Value- MMP-9
Description
Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Time Frame
8 days
Title
Change of Special Biochemical Laboratory Value - MCP-1
Description
Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory
Time Frame
8 days
Title
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8
Description
MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).
Time Frame
Baseline and day 8
Title
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.
Description
MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).
Time Frame
Baseline and day 90
Title
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8
Description
MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.
Time Frame
Baseline and day 8
Title
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90
Description
MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.
Time Frame
Baseline and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
9.182.1 Boehringer Ingelheim Investigational Site
City
Bad Homburg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20060783
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/9/9.182_U10-1162.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/9/9.182_literature.pdf
Description
Related Info
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EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
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