Factors Associated With Premature Termination of Hyperacute Stroke Trials: A Review.

ABSTRACT:

Background

We performed a review of acute stroke trials to determine features associated with premature termination of trial enrollment, defined by the authors as not meeting preplanned sample size.

Methods and results

MEDLINE was searched for randomized clinical stroke trials published in 9 major clinical journals between 2013 and 2022. We included randomized clinical trials that were phase 2 or 3 with a preplanned sample size ≥100 and a time-to-treatment within 24 hours of onset for transient ischemic attack, ischemic stroke, or intracerebral hemorrhage. Data were abstracted on trial features including trial design, inclusion criteria, imaging, location and number of sites, masking, treatment complexity, control group (standard therapy, placebo), industry involvement, and

SUBMITTER: Aziz YN 

PROVIDER: S-EPMC11262524 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature