- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840072
China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)
March 21, 2024 updated by: Jiang He, MD, PhD, Tulane University
Inner Mongolia Stroke Project A Randomized Controlled Trial of Immediate Blood Pressure Reduction on Death and Major Disability in Patients With Acute Ischemic Stroke in China
This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We designed a randomized controlled clinical trial to test:
- The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48 hours of onset) on the primary outcome, a combination of death within 14 days after randomization and dependency (modified Rankin scale ≥3) at 14 day or at the time of discharge, if that occurred before 14 days.
The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48-hours of onset) on secondary outcomes:
- Combination of all-cause mortality and dependency over 3, 12, and 24 months of follow-up
- Combined vascular disease events over 3, 12, and 24 months of follow-up (vascular deaths, non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, hospitalized or treated angina, hospitalized or treated congestive heart failure, and hospitalized or treated peripheral arterial disease)
- Recurrent fatal and non-fatal stroke over 3, 12, and 24 months of follow-up
- Neurological functional status measured by NIH Stroke Score and modified Rankin scale at 14 day or discharge after randomization, and over 3, 12, and 24 months of follow-up
- All-cause mortality over 3, 12, and 24 months of follow-up
- Duration of initial hospitalization
- Changes in systolic and diastolic blood pressure within 24 hours and over 7 days, and 14 days
Study Type
Interventional
Enrollment (Actual)
4071
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215123
- Soohow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥22 years
- Ischemic stroke onset within 48 hours confirmed by imaging (CT scan or MRI) study
- Systolic BP≥140 and <220 mm Hg and diastolic BP≥80 mm Hg
- No contraindications to antihypertensive treatment
- Able and willing to sign informed consent by patients or their direct family members
Exclusion Criteria:
- Individuals with hemorrhagic stroke
- Individuals with severe heart failure (NY Heart Association class III and IV), myocardial infarction, unstable angina, aortic dissection and cerebrovascular stenosis
- Individuals in a deep coma
- Individuals with resistant hypertension [systolic BP ≥170 mm Hg despite use of 4 or more antihypertensive medications for half a year or longer]
- Intravenous thrombolytic therapy (such as intravenous rtPA)
- Individuals who are unable to participate in follow-up examination
- Current pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active antihypertensive treatment
|
Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications.
Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization.
|
No Intervention: Usual care
Discontinue all home BP medications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.
Time Frame: 2 weeks
|
Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 14 days after randomization.
Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.
Time Frame: 3 months
|
Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization.
Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death
|
3 months
|
Mortality
Time Frame: 3 months
|
Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit.
Information on clinical deaths will be obtained.
|
3 months
|
Recurrent Stroke
Time Frame: 3 months
|
Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit.
Information of recurrent stroke will be collected.
|
3 months
|
Other Vascular Events
Time Frame: 3 months
|
Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit.
Information of vascular events, such as myocardial infarction, will be collected.
|
3 months
|
Long-term Neurological and Functional Status
Time Frame: Three months
|
Those patients who were still alive at hospital discharge were contacted by telephone to set up a follow-up clinical visit.
Neurological function was assessed by the modified Rankin scale at the 3-month post-treatment follow-up visit.
Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.
Major disability was defined as a score of 3 to 5 on the modified Rankin Scale.
|
Three months
|
Cognitive Function (the Mini-Mental State Examination)
Time Frame: Three months
|
Cognitive function was measured by the Mini-Mental State Examination at 3 months after randomization.
The MMSE contains 20 items that test cognitive performance in domains including orientation, registration, attention and calculation, recall, language, and visual construction.
MMSE scores were divided into three ordinal categories: 24-30 (no cognitive impairment), 19-23 (mild cognitive impairment), and 0-17 (severe cognitive impairment).
|
Three months
|
Cognitive Function (Montreal Cognitive Assessment)
Time Frame: Three months
|
Cognitive function was measured by Montreal Cognitive Assessment at 3 months after randomization.
The MoCA is a 30-item test that evaluates the following seven cognitive domains: visuospatial/executive functions, naming, memory, attention, language, abstraction, and orientation.
One point is added for participants with education <12 years.
Scores on the MoCA range from 0 to 30 and cognitive impairment was defined as a score of <26.
|
Three months
|
Quality of Life
Time Frame: 3 months
|
Due to limited funding, quality of life data were not collected.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jiang He, MD, PhD, Tulane University SPHTM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- He J, Zhang Y, Xu T, Zhao Q, Wang D, Chen CS, Tong W, Liu C, Xu T, Ju Z, Peng Y, Peng H, Li Q, Geng D, Zhang J, Li D, Zhang F, Guo L, Sun Y, Wang X, Cui Y, Li Y, Ma D, Yang G, Gao Y, Yuan X, Bazzano LA, Chen J; CATIS Investigators. Effects of immediate blood pressure reduction on death and major disability in patients with acute ischemic stroke: the CATIS randomized clinical trial. JAMA. 2014 Feb 5;311(5):479-89. doi: 10.1001/jama.2013.282543.
- Bu X, Li C, Zhang Y, Xu T, Wang D, Sun Y, Peng H, Xu T, Chen CS, Bazzano LA, Chen J, He J; CATIS Investigators. Early Blood Pressure Reduction in Acute Ischemic Stroke with Various Severities: A Subgroup Analysis of the CATIS Trial. Cerebrovasc Dis. 2016;42(3-4):186-95. doi: 10.1159/000444722. Epub 2016 Apr 26.
- Zhong C, Xu T, Xu T, Peng Y, Wang A, Wang J, Peng H, Li Q, Geng D, Zhang D, Zhang Y, Zhang Y, Gao X, He J; CATIS Investigation Groups. Plasma Homocysteine and Prognosis of Acute Ischemic Stroke: a Gender-Specific Analysis From CATIS Randomized Clinical Trial. Mol Neurobiol. 2017 Apr;54(3):2022-2030. doi: 10.1007/s12035-016-9799-0. Epub 2016 Feb 24.
- Bu X, Zhang Y, Bazzano LA, Xu T, Guo L, Wang X, Zhang J, Cui Y, Li D, Zhang F, Ju Z, Xu T, Chen CS, Chen J, He J. Effects of early blood pressure reduction on cognitive function in patients with acute ischemic stroke. Int J Stroke. 2016 Dec;11(9):1009-1019. doi: 10.1177/1747493016660094. Epub 2016 Jul 13.
- Zhai Y, Che B, Liu Y, Peng H, Wang A, Peng Y, Chen J, Zhang Y, Xu T, Zhong C, He J. Effect of Immediate Antihypertensive Treatment on Clinical Outcomes in Acute Ischemic Stroke Patients With Different Renal Function Status. Hypertension. 2023 Jan;80(1):204-213. doi: 10.1161/HYPERTENSIONAHA.122.20202. Epub 2022 Nov 10.
- Du J, Miao M, Lu Z, Chen H, Bao A, Che B, Zhang J, Ju Z, Xu T, He J, Zhang Y, Zhong C. Plasma l-carnitine and risks of cardiovascular events and recurrent stroke after ischemic stroke: A nested case-control study. Nutr Metab Cardiovasc Dis. 2022 Nov;32(11):2579-2587. doi: 10.1016/j.numecd.2022.08.016. Epub 2022 Aug 28.
- Xu T, Zhang K, Zhong C, Zhu Z, Zheng X, Yang P, Che B, Lu Y, Zhang Y. Plasma Human Cartilage Glycoprotein-39 Is Associated With the Prognosis of Acute Ischemic Stroke. J Am Heart Assoc. 2022 Sep 20;11(18):e026263. doi: 10.1161/JAHA.122.026263. Epub 2022 Sep 14.
- Zang Y, Zhu Z, Shi M, Wang A, Xie X, Xu T, Peng Y, Yang P, Li Q, Ju Z, Geng D, Chen J, Liu L, Zhang Y, He J. Association between annual household income and adverse outcomes in patients who had ischaemic stroke. J Epidemiol Community Health. 2022 Mar;76(3):293-300. doi: 10.1136/jech-2021-216481. Epub 2021 Sep 7.
- Zhong C, Miao M, Che B, Du J, Wang A, Peng H, Bu X, Zhang J, Ju Z, Xu T, He J, Zhang Y. Plasma choline and betaine and risks of cardiovascular events and recurrent stroke after ischemic stroke. Am J Clin Nutr. 2021 Oct 4;114(4):1351-1359. doi: 10.1093/ajcn/nqab199.
- Che B, Shen S, Zhu Z, Wang A, Xu T, Peng Y, Li Q, Ju Z, Geng D, Chen J, He J, Zhang Y, Zhong C. Education Level and Long-term Mortality, Recurrent Stroke, and Cardiovascular Events in Patients With Ischemic Stroke. J Am Heart Assoc. 2020 Aug 18;9(16):e016671. doi: 10.1161/JAHA.120.016671. Epub 2020 Aug 11.
- Zhu S, Qian S, Xu T, Peng H, Dong R, Wang D, Yuan X, Guo L, Zhang Y, Geng D, Zhong C. White Matter Hyperintensity, Immediate Antihypertensive Treatment, and Functional Outcome After Acute Ischemic Stroke. Stroke. 2020 May;51(5):1608-1612. doi: 10.1161/STROKEAHA.119.028841. Epub 2020 Apr 1.
- Guo DX, Zhu ZB, Zhong CK, Bu XQ, Chen LH, Xu T, Guo LB, Zhang JT, Li D, Zhang JH, Ju Z, Chen CS, Chen J, Zhang YH, He J. Serum cystatin C levels are negatively correlated with post-stroke cognitive dysfunction. Neural Regen Res. 2020 May;15(5):922-928. doi: 10.4103/1673-5374.268928.
- Zhang R, Zhong C, Zhang Y, Xie X, Zhu Z, Wang A, Chen CS, Peng Y, Peng H, Li Q, Ju Z, Geng D, Chen J, Liu L, Wang Y, Xu T, He J. Immediate Antihypertensive Treatment for Patients With Acute Ischemic Stroke With or Without History of Hypertension: A Secondary Analysis of the CATIS Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e198103. doi: 10.1001/jamanetworkopen.2019.8103.
- Guo D, Zhu Z, Zhong C, Peng H, Wang A, Xu T, Peng Y, Xu T, Chen CS, Li Q, Ju Z, Geng D, Chen J, Zhang Y, He J. Increased Serum Netrin-1 Is Associated With Improved Prognosis of Ischemic Stroke. Stroke. 2019 Apr;50(4):845-852. doi: 10.1161/STROKEAHA.118.024631.
- He WJ, Zhong C, Xu T, Wang D, Sun Y, Bu X, Chen CS, Wang J, Ju Z, Li Q, Zhang J, Geng D, Zhang J, Li D, Li Y, Yuan X, Zhang Y, Kelly TN; CATIS investigators. Early antihypertensive treatment and clinical outcomes in acute ischemic stroke: subgroup analysis by baseline blood pressure. J Hypertens. 2018 Jun;36(6):1372-1381. doi: 10.1097/HJH.0000000000001690.
- Xu T, Zhang Y, Bu X, Wang D, Sun Y, Chen CS, Wang J, Peng H, Ju Z, Peng Y, Xu T, Li Q, Geng D, Zhang J, Li D, Zhang F, Guo L, Wang X, Cui Y, Li Y, Ma D, Zhang D, Yang G, Gao Y, Yuan X, Chen J, He J; CATIS investigators. Blood pressure reduction in acute ischemic stroke according to time to treatment: a subgroup analysis of the China Antihypertensive Trial in Acute Ischemic Stroke trial. J Hypertens. 2017 Jun;35(6):1244-1251. doi: 10.1097/HJH.0000000000001288.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
April 13, 2013
First Submitted That Met QC Criteria
April 22, 2013
First Posted (Estimated)
April 25, 2013
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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