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 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN35624812 |
ClinicalTrials.gov number | NCT00109382 |
Secondary identifying numbers | MCT-63529 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 25/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Alastair Mitchell Buchan
Scientific
Scientific
Room 1162
Foothills Hospital
1403 - 29th Street N.W.
Calgary, Alberta
T2N 2T9
United Kingdom
Study information
Study design | Multicentre randomised controlled double blind trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial |
Study acronym | FASTER |
Study objectives | 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 |
Ethics approval(s) | Ethics approval received from the Health Research Ethics Board of University of Calgary on the 4th October 2004. |
Health condition(s) or problem(s) studied | Stroke |
Intervention | 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 |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Clopidogrel, simvastatin, aspirin |
Primary outcome measure | Any stroke within three months. |
Secondary outcome measures | Composite of any stroke, myocardial infarction and vascular death. |
Overall study start date | 01/04/2003 |
Completion date | 30/03/2004 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 500 |
Key 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 |
Key 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 |
Date of first enrolment | 01/04/2003 |
Date of final enrolment | 30/03/2004 |
Locations
Countries of recruitment
- Canada
- United Kingdom
Study participating centre
Room 1162
Calgary, Alberta
T2N 2T9
United Kingdom
T2N 2T9
United Kingdom
Sponsor information
University of Calgary (Canada)
University/education
University/education
2500 University Drive N.W.
London
NW1 2DA
England
United Kingdom
Website | http://www.ucalgary.ca/ |
---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63529)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/11/2007 | 25/01/2019 | Yes | No |
Editorial Notes
25/01/2019: Publication reference added