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

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
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