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

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any stroke within three months.

Secondary Outcome Measures

Name	Time	Method
Composite of any stroke, myocardial infarction and vascular death.

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