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

FRISC 1996.

Study characteristics
Methods Prospective, multicenter double‐blind, randomized, placebo‐controlled, parallel‐group trial
Participants 1506 patients with unstable CAD (unstable angina or non‐Q‐wave myocardial infarction)
admitted to hospital with chest pain within the previous 72 hours.
Interventions 2 treatment groups, ASA 300 mg/d (then 75 mg) + one of;
Group 1: dalteparin 120 IU/kg SC twice daily x 6 days, then 7500 IU daily for 35‐45 days.
Group 2: placebo.
Outcomes Primary outcome: Difference in the rate of death, new MI during the first 6 days of treatment (acute phase).
Secondary outcomes: death and MI after 35‐45 days, revascularization procedures, major/minor bleeding, thrombocytopenia and need for IV heparin (nIVH).
Notes Acute phase data used for death and MI outcomes.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization done in blocks
Allocation concealment (selection bias) Unclear risk Quote: “Placebo was packaged in matching ampoules and syringes” (identical appearance) but, they don’t describe the method of concealment in sufficient detail (it´s unclear if they were sequentially numbered.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinding of participants and personnel likely.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk This study did not address this outcome.
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing outcome data balanced in numbers across groups (follow‐up was incomplete in 8 patients [5 dalteparin, 3 placebo]).
Selective reporting (reporting bias) Low risk No protocol available, all expected outcomes reported.
Other bias Low risk