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

Fang Yuan, Fang Yang, Changhu Xue, Kangjun Wang, Qiuwu Liu, Jun Zhou, Feng Fu, Xiaocheng Wang, Wei Zhang, Yi Liu, Kang Huo, Hua Lv, Wen Jiang, CHASE Study Group, Fang Yuan, Fang Yang, Changhu Xue, Kangjun Wang, Qiuwu Liu, Jun Zhou, Feng Fu, Xiaocheng Wang, Wei Zhang, Yi Liu, Kang Huo, Hua Lv, Wen Jiang, CHASE Study Group

Abstract

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.

Keywords: Blood pressure; Critical care; Hypertension; Prognosis; Severe stroke.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the ethics committees of Xijing Hospital, the Fourth Military Medical University, on 22 November 2016 (KY20162085-2). Written informed consent to participate will be obtained from each participant. A copy of the case report form and consent form can be obtained from the corresponding author. Potential protocol modifications will be formally approved by the Research Ethics Committee before being implemented.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of participants in the CHASE trial. BP blood pressure, GCS Glasgow Coma Scale, NIHSS National Institute of Health stroke scale, SBP systolic blood pressure

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