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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) | Drug | |||
| ASA 100 mg qd | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 90 days |
| Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding) |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 9.182.1 Boehringer Ingelheim Investigational Site | Bad Homburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20060783 | Derived | 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. |
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551 patients enrolled, 548 randomized, 543 treated; analysis is based on treated patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin for 7 Days, Followed by Aggrenox | ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d |
| FG001 | Aggrenox | Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin for 7 Days, Followed by Aggrenox | ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d |
| BG001 | Aggrenox | Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Number | participants | 90 days |
|
Up to 90 days
From first drug intake until date of last drug intake
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin for 7 Days, Followed by Aggrenox | ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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) | 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) | 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 | 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 | 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 | 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). | 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). | 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. | 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. | Baseline and day 90 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
|
|
|
| Secondary | 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) | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Median | Inter-Quartile Range | Units on a scale | Baseline and 90 days |
|
|
|
|
| Secondary | Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding) | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Number | participants | 90 days |
|
|
|
|
| Secondary | 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) | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Number | participants | 8 days |
|
|
|
| Secondary | 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) | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 days |
|
|
|
| Secondary | 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 | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Geometric Mean | 95% Confidence Interval | mg/L | 8 days |
|
|
|
| Secondary | 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 | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 8 days |
|
|
|
| Secondary | 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 | FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 8 days |
|
|
|
| Secondary | 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). | Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 8. | Posted | Median | Inter-Quartile Range | mL | Baseline and day 8 |
|
|
|
| Secondary | 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). | Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 90. | Posted | Median | Inter-Quartile Range | mL | Baseline and day 90 |
|
|
|
| Secondary | 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. | Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 8. | Posted | Median | Inter-Quartile Range | mL | Baseline and day 8 |
|
|
|
| Secondary | 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 Analysis Set - included all randomised patients who had value in DWI at baseline and day 90. | Posted | Median | Inter-Quartile Range | mL | Baseline and day 90 |
|
|
|
| 48 |
| 260 |
| 60 |
| 260 |
| EG001 | Aggrenox | Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d | 45 | 283 | 119 | 283 |
| Carotid artery stenosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Basilar artery thrombosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Brain stem stroke | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diabetic coma | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyponatraemic encephalopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular dyskinesia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac pacemaker malfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Tracheostomy malfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arterial repair | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| Missing |
|