Cerebrovascular AccidentPhase 4NCT00562588
EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA
A Phase 4 study testing Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) and ASA 100 mg qd in people with Cerebrovascular Accident, run by Boehringer Ingelheim at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) and ASA 100 mg qd
- How many people
- 551 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg), ASA 100 mg qd
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg)Drug
ASA 100 mg qdDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days
Secondary outcomes (11)
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)
Measured: Baseline and 90 days
Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)
Measured: 90 days
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)
Measured: 8 days
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)
Measured: Baseline and 8 days
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
Measured: 8 days
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
Measured: 8 days
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
Measured: 8 days
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).
Measured: Baseline and day 8
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).
Measured: Baseline and day 90
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.
Measured: Baseline and day 8
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.
Measured: Baseline and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562588
- Sponsor's protocol ID
- 9.182
- Status last verified
- Jan 2014
- First submitted
- 6 Jul 2007
- Last updated
- 19 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20060783
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00562588
- Acronym / sponsor ID
- 9.182
- Conditions
- Cerebrovascular Accident
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Posted 11 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) | Drug | – |
| ASA 100 mg qd | Drug | – |
Primary outcome
Telephone Modified Rankin Scale (Centralised, Blinded Assessment)
Time frame: 90 days
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)
11 secondary outcomes
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)
Time frame: Baseline and 90 days
Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)
Time frame: 90 days
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8
Time frame: 8 days
Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8
Time frame: Baseline and 8 days
Change of Special Biochemical Laboratory Value- CRP
Time frame: 8 days
Change of Special Biochemical Laboratory Value- MMP-9
Time frame: 8 days
Change of Special Biochemical Laboratory Value - MCP-1
Time frame: 8 days
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8
Time frame: Baseline and day 8
Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.
Time frame: Baseline and day 90
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8
Time frame: Baseline and day 8
Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90
Time frame: Baseline and day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20060783Dengler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) and ASA 100 mg qd in people with Cerebrovascular Accident, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.