Clinical trial NCT00109382 (phase 2/phase 3, status: completed)
Conditions: transient ischemic attack, stroke
ICD codes: G45.9, Z86.73, G45.8, G46.4, G46.3, Z82.3
Drugs: aspirin, clopidogrel, simvastatin
SMILES: CC(=O)OC1=CC=CC=C1C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O, CC1=CC(O)=CC(C)=C1Cl
Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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