FASTER PILOT.
Study characteristics | ||
Methods | Double‐blinded RCT | |
Participants | 185 women and 187 men recruited in the trial. Participants had a history of stroke or TIA. Age of participants had to be greater than 40 years and should not have been eligible for thrombolysis or acute intervention. Symptoms present for at least 5 minutes and included weakness or language disturbance. Enrolment must be done within 24 hours of symptom onset. Exclusion criteria included pure sensory symptoms, presumed cardiac source of emboli, and stroke/TIA mimics. 194 participants assigned to groups without clopidogrel (control) and 198 participants assigned to clopidogrel group. Participants were followed up in clinic at 10 days and 90 days. 1 participant was lost to follow‐up in each group. |
|
Interventions | Aspirin 81 mg (day 1: aspirin 162 mg) once daily plus clopidogrel 75 mg (300 mg loading dose) once daily vs aspirin only 81 mg (day 1: aspirin 162 mg) To ensure follow‐ups, telephone calls were made at 2, 30, 60, and 90 days. |
|
Outcomes | Primary outcome: any stroke at 90 days Secondary outcome: composite of any stroke, MI, and vascular death |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation |
Allocation concealment (selection bias) | Low risk | Pharmacist provided predetermined kits. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 (1.8%) participants lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported |