PASSReviewer 1· 85% conf
The study design is rigorous for a randomized controlled trial, with clear randomization, blinding, and pre-specified analyses, though the follow-up extension lacks a formal power calculation.
Evidence
direct quote[Methods, Study design]
“randomised 1:1:1 to ticagrelor 90 mg twice daily plus aspirin 100 mg once daily (dual antiplatelet therapy), ticagrelor monotherapy 90 mg twice daily, or aspirin monotherapy 100 mg once daily”direct quote[Methods, Study design]
“open label, evaluator blind, randomised, controlled trial”direct quote[Methods, Statistical analysis]
“For the DACAB-FE study, we did no formal power calculation.”PASSReviewer 2· 90% conf
The study design is rigorous for a follow-up of an RCT, with clear randomization, blinding, and analysis methods.
Evidence
direct quote[Methods, Study design]
“eligible patients were enrolled from 31 July 2014 through 3 November 2015 and randomised 1:1:1 to ticagrelor 90 mg twice daily plus aspirin 100 mg once daily (dual antiplatelet therapy), ticagrelor monotherapy 90 mg twice daily, or aspirin monotherapy 100 mg once daily for one year after coronary artery bypass graft surgery.”direct quote[Methods, Study design]
“The DACAB trial was a prospective, multicentre, open label, evaluator blind, randomised, controlled trial”direct quote[Methods, Statistical analysis]
“The sample size for the DACAB trial was based on a calculated statistical power of 80% to detect a significant difference in the primary outcome of vein graft patency. For the DACAB-FE study, we did no formal power calculation.”