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. 2014 Jun 27;2014(6):CD003462. doi: 10.1002/14651858.CD003462.pub3

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).
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)
Outcomes Outcomes at 5 days, 30 days and 90 days.
Primary outcome: Death or MI (90 days), revascularization,
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