China Antihypertensive Trial in Acute Ischemic Stroke II (CATIS-2)
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|ClinicalTrials.gov Identifier: NCT03479554|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Other: Early antihypertensive treatment Other: Delayed antihypertensive treatment||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4776 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Randomization will be conducted centrally at the SDCC. The randomization will be stratified by participating hospitals and use of antihypertensive medication. In each stratum, patients will be randomly assigned to the early antihypertensive treatment group or the delayed antihypertensive treatment group within each block. The block size will be random among 4, 6, and 8. The early BP lowering group will receive antihypertensive treatment immediately according to the study protocol, and the delayed BP lowering group will discontinue antihypertensive treatment for the first seven days after randomization.
The randomization schedules will be generated using SAS PROC PLAN in SAS and will be concealed at the SDCC. When an eligible participant is ready for randomization, the site investigator/study coordinator will log-in to a password-protected website to obtain the randomization assignment.
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||The study physicians and nurses will not be masked to patients' randomization assignments because of the different time points for initiating BP treatment between the two randomization groups. The data on BP will also be unmasked because they are management tools for attaining the specific treatment targets. However, the study neurologists and nurses who conduct the neurological and functional assessments and collect clinical outcome data at the baseline and follow-up examinations will be masked to patients' assignments. The members of the Outcome Adjudication Committee will also be masked to patients' randomization.|
|Official Title:||China Antihypertensive Trial in Acute Ischemic Stroke II|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Early antihypertensive treatment group
BP-lowering treatment will start immediately after randomization in the early antihypertensive treatment group.
Other: Early antihypertensive treatment
The CATIS 2 trial is designed to test BP reduction strategies‒early antihypertensive treatment vs. delayed antihypertensive treatment‒rather than test the efficacy of individual antihypertensive drugs. Several antihypertensive agents, including angiotensin-converting enzyme inhibitors, calcium channel blockers, and diuretics will be used in the trial.
BP-lowering treatment will start immediately after randomization in the early antihypertensive treatment group. The target treatment goals are:
Active Comparator: Delayed antihypertensive treatment group
All home antihypertensive medications will be discontinued in the first seven days after randomization. Study participants will receive antihypertensive treatment on day eight after randomization.
Other: Delayed antihypertensive treatment
All home antihypertensive medications will be discontinued in the first seven days after randomization. Study participants will receive antihypertensive treatment on day eight after randomization and will target systolic BP <140 mmHg (but not lower than 120 mmHg) and diastolic BP <90 mmHg (but not lower than 70 mmHg) in two weeks. A BP check-up visit will be conducted in two weeks. If BP treatment goal is not achieved, antihypertensive medication will be titrated or a new medication will be added.
- Composite outcome of death and major disability [ Time Frame: At 3 months ]The primary endpoint for the CATIS-2 trial is a composite outcome of death and major disability (modified Rankin score ≥3) at 3 months.
- Recurrent stroke [ Time Frame: At 3 months ]The first recurrent stroke event (hemorrhagic or ischemic) over three months of follow-up.
- Modified Rankin Scale [ Time Frame: At 3 months ]Ordered 7-level categorical score of the modified Rankin Scale
- All-cause mortality [ Time Frame: At 3 months ]Total mortality from all causes
- Major vascular disease events [ Time Frame: At 3 months ]Vascular deaths, non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, hospitalized or treated angina, and hospitalized or treated congestive heart failure
- Cognitive impairment [ Time Frame: At 3 months ]Vascular cognitive impairment measured by the MoCA
- Quality of life [ Time Frame: At 3 months ]Health-related quality of life measured by the 12-item Short Form
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479554
|Contact: Jiang He, MD, PhDfirstname.lastname@example.org|
|Contact: Yilong Wang, MD, PhDemail@example.com|
|Beijing Tiantan Hospital||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Xuewei Xie, MD, PhD (86 10) 6709-8222 firstname.lastname@example.org|
|Principal Investigator:||Jiang He, MD, PhD||Tulane University|
|Principal Investigator:||Yilong Wang, MD, PhD||Beijing Tiantan Hospital|
|Principal Investigator:||Liping Liu, MD, PhD||Beijing Tiantan Hospital|