Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00109382
Protocol/serial number
MCT-63529
Study information
Scientific title
Acronym
FASTER
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Clopidogrel, simvastatin, aspirin
Primary outcome measures
Any stroke within three months.
Secondary outcome measures
Composite of any stroke, myocardial infarction and vascular death.
Overall trial start date
01/04/2003
Overall trial end date
30/03/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant 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
Recruitment start date
01/04/2003
Recruitment end date
30/03/2004
Locations
Countries of recruitment
Canada
Trial participating centre
Room 1162
Calgary, Alberta
T2N 2T9
Canada
Sponsor information
Organisation
University of Calgary (Canada)
Sponsor details
2500 University Drive N.W.
Calgary
Alberta
T2N 1N4
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63529)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary