Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)

Completed · Phase 2/Phase 3

Conditions studied: Transient Ischemic Attack, Stroke

In brief

Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the three months following TIA occurring within 48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this risk. The FASTER trial is focusing on the initial period of high risk, starting patients on stroke prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested have been shown to be effective in the similar setting of cardiology, reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event. All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke. It will also look if the very early introduction of simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients.

Key facts

Study ID: NCT00109382
Run by: University of Calgary
People needed: 500
Starts: 2003-05-01
Expected to finish: 2007-02-01
Last updated by the study team: 2008-04-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with TIA or minor acute ischemic stroke (NIHSS < 4 at the time of randomization) who must NOT be candidates for acute thrombolysis or other acute intervention indicated as the current standard of care
Aged 40 years or older
Patients with: (a) weakness at time of TIA/minor stroke and/or language disturbance at time of TIA/minor stroke and; (b) duration of neurological deficit (TIA) > 5 minutes
Patients can be randomized within 24 hours of symptom onset. Symptom onset is defined by the "last seen well" principle
Patients must have provided written, informed consent to participate in the FASTER trial.

You may not qualify if…

Patients with pure sensory symptoms, pure vertigo or dizziness, pure ataxia or pure visual loss
Patients for whom thrombolysis or other acute intervention is indicated as the current standard of care
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
Patients who in the opinion of the site Investigator, should be commenced on statin therapy
Patients with neurological deficit due to intracranial hemorrhage (intracranial hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma), tumor, infection or any finding not consistent with acute brain ischemia as the cause of presenting symptoms
Presumed cardiac source of embolus (e.g. atrial fibrillation, prosthetic cardiac valve, known/suspected endocarditis)
Patient with a concomitant acute coronary syndrome (acute myocardial infarction or unstable angina)
Modified Rankin Score 3 or more (pre-morbid historical assessment)
Patients in whom the qualifying event was due to a complication of cerebral angiography, a revascularization procedure or trauma
Uncontrolled hypertension at baseline (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), or malignant hypertension defined by brain plus acute organ involvement due to acute hypertension
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
Evidence of contraindication for use of Trial Medication: (i) serious systemic bleeding precluding antiplatelet therapy; (ii) hypersensitivity to aspirin, thienopyridine drugs (clopidogrel or ticlopidine) or statins; (iii) current or past history of renal insufficiency [serum Creatinine >150 umol]; (iv) hepatic dysfunction indicated by any or all of the following [ALT >3xULN, AST >3xULN, ALP >3xULN]; (v) thrombocytopenia [platelet count < 150 x10\^9/L]; (vi) neutropenia [neutrophil count < 0.5 x10\^9/L]; (vii) bleeding diathesis or coagulopathy indicated by any or all of the following [INR >1.2, PT >1.2xULN, PTT >1.2xULN]
Life expectancy of less than 90 days
Participation in another clinical therapeutic trial (drug or device) either concurrently or within the previous 30 days, or prior participation in FASTER
Geographical or other factors that render follow-up impractical or that render evaluation of outcome events impossible (e.g. severe dementia). Patients may be randomized who could and are willing to complete their follow-up at a participating centre

Where it is running

University of Pennsylvania — Philadelphia, Pennsylvania, United States
Foothills Medical Centre — Calgary, Alberta, Canada
Universtiy of Alberta Walter MacKenzie Health Sciences Centre — Edmonton, Alberta, Canada
University of Lethbridge Hospital — Lethbridge, Alberta, Canada
Vancouver General Hospital — Vancouver, British Columbia, Canada
St. Paul's Hospital — Vancouver, British Columbia, Canada
Centre for Stroke Research — Victoria, British Columbia, Canada
St. John Regional Hospital — Saint John, New Brunswick, Canada
Queen Elizabeth ll Health Sciences Centre — Halifax, Nova Scotia, Canada
London Health Sciences Centre - University Hospital — London, Ontario, Canada
Trillium Health Centre — Mississauga, Ontario, Canada
Ottawa Hospital — Ottawa, Ontario, Canada
Sunnybrook Women's Health Centrre — Toronto, Ontario, Canada
St. Mike's Hospital — Toronto, Ontario, Canada
Toronto Western Hospital -University Health Network — Toronto, Ontario, Canada
Chicoutimi Hospital — Chicoutimi, Quebec, Canada
Hopital Charles LeMoyne — Greenfield Park, Quebec, Canada
Hopital Notre-Dame du CHUM — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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