China Antihypertensive Trial in Acute Ischemic Stroke II (CATIS-2): rationale and design

Liping Liu, Yilong Wang, Xuewei Xie, Dacheng Liu, Aili Wang, Penglian Wang, Suwen Shen, Chongke Zhong, Yufei Wei, Tan Xu, Yuesong Pan, Yong Jiang, Xia Meng, David Wang, Yonghong Zhang, Jiang He, Yongjun Wang, Liping Liu, Yilong Wang, Xuewei Xie, Dacheng Liu, Aili Wang, Penglian Wang, Suwen Shen, Chongke Zhong, Yufei Wei, Tan Xu, Yuesong Pan, Yong Jiang, Xia Meng, David Wang, Yonghong Zhang, Jiang He, Yongjun Wang

Abstract

Backgrounds: Increased blood pressure (BP) for patients who had an acute ischaemic stroke is associated with poor functional outcome, however the optimal timing of antihypertensive therapy is unknown.

Aims: We aim to compare early antihypertensive treatment to delayed antihypertensive treatment for reducing the risk of composite major disability and mortality at 3 months in acute ischaemic stroke.

Design: The China Antihypertensive Trial in Acute Ischemic Stroke II (CATIS-2) trial is a multicentre, randomised, open-label, blinded-endpoints trial that will be conducted in 100 hospitals in China. The primary outcome is the composite of death and major disability (modified Rankin Scale score ≥3) at 3 months of randomisation. Antihypertensive treatment will be received immediately after randomisation in the early treatment group, aimed at average systolic BP by 10%-20% reduction within the first 24 hours, and achieving an average BP level of <140/90 mm Hg within 5 days. Patients in the delayed treatment group will discontinue any antihypertension medications for the first 7 days of randomisation, and will receive antihypertensive therapy achieving a BP goal of <140/90 mm Hg after 7 days.

Conclusion: The CATIS-2 trial will be testing the hypotheses that early BP lowering leads to improved functional outcome without any other harms, and developing clinical guidelines of the BP management for patients who had an acute ischaemic stroke.

Trial registration number: NCT03479554.

Keywords: stroke.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Treatment algorithm for early antihypertensive treatment group. BP, blood pressure; CCB, calcium channel blockers; SBP, systolic BP.

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