Controlling Hypertension After Severe Cerebrovascular Event (CHASE): study protocol for a randomized controlled trial.

BACKGROUND: No ideal blood pressure (BP) range has been scientifically determined for acute stroke, and no studies on BP management have been carried out for patients with severe stroke. This trial aims to investigate whether individualized lowering of elevated BP would improve the outcome in patients with severe stroke.

METHODS/DESIGN: The CHASE trial is a multicenter, randomized, controlled study. A total of 500 adult patients with acute severe stroke will be enrolled in 18 study sites in China and randomized to individualized BP lowering (10-15% reduction from admission level) or guideline-recommended BP lowering. The primary outcome measurement is the proportion of participants with a poor outcome (modified Rankin Scale ≥ 3) at day 90 of enrollment. Secondary outcomes include disability at hospital discharge and the ability of activities of daily living at day 90 of enrollment. The relationship between intervention and the primary outcome will be analyzed using multivariate logistic regression adjusted for study site, demographics, and baseline characteristics.

DISCUSSION: The CHASE trial will be the first study to explore the optimum BP management for acute severe stroke. This trial potentially offers a strong argument for individualized target for lowering elevated BP in patients with severe stroke.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT02982655 . Registered on 30 November 2016.