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| Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) : a pilot study for a multicentre randomised controlled, double blind trial of combination anti-platelet therapy versus aspirin and statin therapy to prevent stroke in those at high-risk of early recurrence after transient ischemic attack or mild stroke |
| ISRCTN | ISRCTN35624812 |
| ClinicalTrials.gov identifier | NCT00109382 |
| Public title | Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) : a pilot study for a multicentre randomised controlled, double blind trial of combination anti-platelet therapy versus aspirin and statin therapy to prevent stroke in those at high-risk of early recurrence after transient ischemic attack or mild stroke |
| Scientific title | |
| Acronym | FASTER |
| Serial number at source | MCT-63529 |
| Study hypothesis |
1. To determine whether a rapid commencement of clopidogrel plus aspirin (ASA) within 12 hours of acute transient ischemic attack (TIA) or minor stroke is more effective than ASA in reducing the 90-day risk of stroke by an absolute difference of 2%
2. To determine whether a rapid commencement of simvastatin plus ASA within 12 hours of acute TIA or minor stroke is more effective than ASA in reducing the 90-day risk of stroke by an absolute difference of 2% 3. To determine whether a rapid commencement of clopidogrel plus simvastatin plus ASA within 12 hours of acute TIA or minor stroke is more effective than ASA in reducing the 90-day risk of stroke by an absolute difference of 4% 4. To determine whether the incidence of adverse events is different among treatment groups |
| Lay summary | |
| Ethics approval | Ethics approval received from the Health Research Ethics Board of University of Calgary on the 4th October 2004. |
| Study design | Multicentre randomised controlled double blind trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
1. Patients with TIA or minor acute ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] equalling 3 at the time of randomisation) who must not be candidates for acute thrombolytic or anticoagulant therapy within 12 hours of symptom onset
2. Aged 40 years or over, either sex 3. Patients with: 3.1. Weakness at time of TIA/minor stroke and/or language disturbance at time of TIA/minor stroke 3.2. Duration of neurological deficit (TIA) equals 5 minutes 4. Patients can be randomised within 12 hours of symptom onset. Symptom onset is defined by the 'last seen well' principle |
| Participants - exclusion criteria |
1. Patients with pure sensory symptoms, pure vertigo or dizziness, or pure visual loss
2. Patients for whom thrombolysis or other acute intervention is indicated as the current standard of care 3. Patients who are currently on statin therapy, antiplatelet therapy (not including aspirin), or long-term Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, but not COX inhibitors), or anticoagulation 4. Patients, who in the opinion of the site Investigator, should be commenced on statin therapy 5. Patients with neurological deficit due to intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma), tumor, infection or any finding not consistent with acute brain ischemia as the cause of presenting symptoms 6. Presumed cardiac source of embolus (e.g. atrial fibrillation, prosthetic cardiac valve, known/suspected endocarditis) 7. Patient with a concomitant acute coronary syndrome (acute myocardial infarction or unstable angina) 8. Modified Rankin Score of 3 or more (pre-morbid historical assessment) 9. Patients in whom the qualifying event was due to a complication of cerebral angiography, a revascularization procedure or trauma 10. Uncontrolled hypertension at baseline (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg), or malignant hypertension defined by brain plus other acute organ involvement due to acute hypertension 11. Women who are breast-feeding or pregnant. Women of childbearing potential must have a negative pregnancy test prior to randomization. Women of childbearing potential may still participate in the trial but must plan on not becoming pregnant during the course of the study and must practice a suitable method of birth control. If a patient becomes pregnant or begins breast-feeding during the study, both study drugs will be discontinued immediately, and the patient followed for the duration of the study 12. Evidence of contraindication for use of Trial Medication: 12.1. Current or past history of severe renal insufficiency 12.2. Current or past history of severe hepatic dysfunction 12.3. Current or past history of thrombocytopenia 12.4. Current or past history of neutropenia 12.5. Current or past history of bleeding diathesis or coagulopathy 12.6. Current or past history of serious systemic bleeding 12.7. Past History of hypersensitivity to aspirin, thienopyridine drugs (clopidogrel or ticlopidine) or statins 13. Life expectancy of less than 90 days 14. Geographical or other factors that render follow-up impractical or that render evaluation of outcome events impossible (e.g. severe dementia). Patients may be randomised who could and are willing to complete their follow-up at another participating centre 15. Participation in another clinical therapeutic trial (drug or device) either concurrently or within the previous 30 days, or prior participation in FASTER |
| Anticipated start date | 01/04/2003 |
| Anticipated end date | 30/03/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 500 |
| Interventions |
All patients will receive open-label enteric-coated aspirin in the range of 81 mg, with dose determined by the treating physician.
Arm 1: Clopidogrel 300 mg + simvastatin 40 mg on day 1, then clopidogrel 75 mg once daily (OD) + simvastatin 40 mg OD on days 2 - 90 Arm 2: 4 Clopidogrel-placebo tablets + simvastatin 40 mg on day 1, then clopidogrel-placebo tablet OD + simvastatin 40 mg OD on days 2 - 90 Arm 3: Clopidogrel 300 mg + 1 simvastatin-placebo tablet on day 1, then clopidogrel 75 mg OD + 1 simvastatin-placebo tablet OD on days 2 - 90 Arm 4: 4 Clopidogrel-placebo tablets + 1 simvastatin-placebo tablet on day 1, then 1 clopidogrel-placebo tablet OD + 1 simvastatin-placebo tablet OD on days 2 - 90 |
| Primary outcome measure(s) | Any stroke within three months. |
| Secondary outcome measure(s) | Composite of any stroke, myocardial infarction and vascular death. |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63529) |
| Trial website | |
| Publications | |
| Contact name | Prof Alastair Mitchell Buchan |
| Address |
Room 1162
Foothills Hospital 1403 - 29th Street N.W. |
| City/town | Calgary, Alberta |
| Zip/Postcode | T2N 2T9 |
| Country | Canada |
| Sponsor | University of Calgary (Canada) |
| Address | 2500 University Drive N.W. |
| City/town | Calgary, Alberta |
| Zip/Postcode | T2N 1N4 |
| Country | Canada |
| Sponsor website: | http://www.ucalgary.ca/ |
| Date applied | 01/09/2005 |
| Last edited | 10/12/2007 |
| Date ISRCTN assigned | 01/09/2005 |
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