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. |
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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. |
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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). |
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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 |