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Controlling Hypertension After Severe Cerebrovascular Event (CHASE): study protocol for a randomized controlled trial
Fang Yuan1, Fang Yang1, Changhu Xue2
1Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, 710032, China.
Insights
This study investigates individualized blood pressure (BP) lowering for severe stroke patients. Results will guide optimal BP management in acute stroke care.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Clinical Trials
Background:
- Optimal blood pressure (BP) targets for acute stroke remain undetermined.
- No prior studies have specifically addressed BP management in severe stroke patients.
Purpose of the Study:
- To investigate if individualized lowering of elevated BP improves outcomes in patients with acute severe stroke.
- To establish optimal BP management strategies for severe stroke.
Main Methods:
- The CHASE trial is a multicenter, randomized, controlled study involving 500 adult patients with acute severe stroke.
- Participants were randomized to either individualized BP lowering (10-15% reduction) or guideline-recommended BP lowering.
- Primary outcome: proportion of participants with a poor outcome (modified Rankin Scale ≥3) at 90 days.
Main Results:
- Analysis of primary outcome using multivariate logistic regression adjusted for covariates.
- Evaluation of secondary outcomes including disability at discharge and daily living activities at 90 days.
Conclusions:
- The CHASE trial is the first to explore optimum BP management for acute severe stroke.
- Findings may provide evidence for individualized BP lowering targets in severe stroke patients.
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.
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