Preservation of Type I Error for Partially-Unblinded Sample Size Re-Estimation.

Sample size re-estimation (SSR) at an interim analysis allows for adjustments based on accrued data. Existing strategies rely on either blinded or unblinded methods to inform such adjustments and, ideally, perform these adjustments in a way that preserves Type I error at the nominal level. Here, we propose an approach that uses partially-unblinded methods for SSR for both binary and continuous endpoints.

Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial.

Importance: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that in 1708 patients with stable coronary disease and prior myocardial infarction (MI), oral multivitamins and multiminerals (OMVMs), in a factorial design with edetate disodium (EDTA) chelation therapy, did not reduce cardiovascular events relative to placebo OMVMs, but active EDTA combined with active OMVMs was superior to placebo OMVM/placebo EDTA.

Objective: To compare OMVM vs placebo in terms of efficacy for reducing major adverse cardiovascular events in patients with diabetes and prior MI.

Design, Setting, And Participants: The TACT2 randomized, multicenter double-masked 2 × 2 factorial clinical trial took place across 88 sites in the US and Canada.

Baseline characteristics of contemporary trial participants with heart failure and reduced ejection fraction: The VICTOR trial.

Aims: To describe the baseline characteristics of the participants in the VICTOR (Vericiguat Global Study in Patients with Chronic Heart Failure; NCT05093933) trial and compare them to recent trials in patients with heart failure and reduced ejection fraction (HFrEF).

Methods And Results: Baseline characteristics were evaluated in 6105 patients randomized to vericiguat or placebo. The mean age of the participants was 67 ± 11 years, 23.

Economic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial.

Background: The PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) demonstrated that a precision diagnostic strategy reduced the primary composite of death, nonfatal myocardial infarction, or catheterization without obstructive coronary artery disease by 65% in patients with nonacute chest pain compared with usual testing. Medical cost was a prespecified secondary end point.

Methods: PRECISE randomized 2103 patients between December 2018 and May 2021 to usual testing or a precision strategy that used deferred testing for the lowest risk patients (20%) and coronary computed tomographic angiography with selective computed tomography-derived fractional flow reserve for the remainder.

Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial.

Background: The PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) trial compared an investigational precision diagnostic testing strategy (n=1057) with usual testing (n=1046) in patients with stable chest pain and suspected coronary artery disease. Quality of life (QOL) outcomes were a prespecified secondary end point.

Methods: We assessed QOL by structured interviews in all trial participants at baseline and 45 days, 6 months, and 12 months postrandomization.