RISC 1990.
Study characteristics | ||
Methods | Prospective, randomized, double‐blind, placebo‐controlled multicenter trial. | |
Participants | 796 patients (<70 years old) with unstable angina or NSTEMI. Chest pain occurring within previous 4 weeks (randomized to treatment up to 72 hours after admission). |
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Interventions | 4 treatment groups, Group 1: ASA placebo + UFH placebo Group 2: ASA placebo + UFH 5000 U IV 6 hourly x 1 day, then 3750 IV 6 hourly x 4 days Group 3: ASA 75 mg/d + UFH placebo (n = 189) Group 4: ASA 75 mg/d + UFH (same as group 2) (n = 210) |
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Outcomes | Outcomes at 5 days, 30 days and 90 days. Primary outcome: Death or MI (90 days), revascularization, |
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Notes | Only used data from groups 3 and 4. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. Probably not done. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Trial labeled as “double‐blind” but the study did not address this further |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The study did not address this outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across groups. Quote: “After 3 months, 95% of patients remained on treatment with no difference between the aspirin and placebo groups” |
Selective reporting (reporting bias) | Low risk | No protocol available, all expected outcomes reported. |
Other bias | Low risk | Early conclusion of the study recommended by the safety committee, the follow‐up was planned for 1 year (it was reduced to 3 months), probably not a risk of bias for this |