Théroux 1988.
Study characteristics | ||
Methods | Prospective, randomized, double‐blind study | |
Participants | 479 patients with unstable angina (admitted or while hospitalized), within 24 hours preceding the time of randomization | |
Interventions | 4 treatment groups (6 days of therapy), Group 1: ASA 650 mg, then 325 mg bid + UFH placebo (n = 121) Group 2: UFH 5000 U, then 1000 U/hour + placebo ASA Group 3: ASA 650 mg, then 325 mg bid + UFH 5000 U IV, then 1000 U/hour (n = 122) Group 4: placebo + placebo UFH |
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Outcomes | Primary outcome (6 days and 3 months): refractory angina, MI, death, serious (major) bleeding | |
Notes | Study was discontinued prematurely on the basis of first interim data analysis. Use only data from Groups 1 and 3 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization done in blocks |
Allocation concealment (selection bias) | Low risk | Pharmacy‐controlled randomization (central) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding probably ensured. Quote: “trial medication prepackaged and coded by the pharmacists on a randomized, double‐blind basis” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Some key study personnel probably not blinded, but, outcome measurement are not likely to be influenced by the lack of blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | No protocol available, all expected outcomes reported. |
Other bias | High risk | The study was discontinued prematurely on the basis of the policy board recommendation after the first interim data analysis |
aPTT ‐ activated partial thromboplastin time ASA ‐ aspirin CAD ‐ coronary artery disease INR ‐ international normalized ratio IV ‐ intravenous MI ‐ myocardial infarction NSTEMI ‐ non‐ST segment myocardial infarction SC ‐ subcutaneous UFH ‐ unfractionated heparin