Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
4071 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-08-31
Study Completion Date
2016-05-31
Brief Summary
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This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.
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Detailed Description
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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
* 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
Conditions
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Ischemic Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Active antihypertensive treatment
Active antihypertensive treatment
Group Type
EXPERIMENTAL
Active antihypertensive treatment
Intervention Type
OTHER
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.
Usual care
Discontinue all home BP medications.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
22 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Soochow University
OTHER
Sponsor Role
collaborator
Tulane University
OTHER
Sponsor Role
lead
Responsible Party
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Jiang He, MD, PhD
Professor and Department Chair
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jiang He, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tulane University SPHTM
Locations
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Soohow University
Suzhou, Jiangsu, China
Site Status
Countries
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China
References
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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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Wang M, Long J, Yuan K, Cao M, Peng Y, Xu T, He J, Zhang Y, Zhong C, Zhai G. Soluble Triggering Receptor Expressed on Myeloid Cells 2 as a Promising Biomarker for Poststroke Depression After Acute Ischemic Stroke. J Am Heart Assoc. 2025 Sep 16;14(18):eJAHA2024040555T. doi: 10.1161/JAHA.124.040555. Epub 2025 Aug 22.
Reference Type
DERIVED
Wang M, Zhu S, Long J, Cao M, Peng Y, Chen J, Xu T, He J, Zhang Y, Zhong C. Efficacy of immediate anti-hypertensive treatment in patients with acute ischaemic stroke stratified by mean arterial pressure and pulse pressure: a secondary analysis of the China Antihypertensive Trial in Acute Ischemic Stroke trial. Stroke Vasc Neurol. 2025 Apr 23:svn-2024-003896. doi: 10.1136/svn-2024-003896. Online ahead of print.
Reference Type
DERIVED
Wang Z, Zhang K, Zhong C, Zhu Z, Zheng X, Yang P, Che B, Lu Y, Zhang Y, Xu T. Plasma human cartilage glycoprotein-39 and depressive symptoms among acute ischemic stroke patients. Gen Hosp Psychiatry. 2025 May-Jun;94:120-125. doi: 10.1016/j.genhosppsych.2025.03.003. Epub 2025 Mar 6.
Reference Type
DERIVED
Wang Z, Zhang K, Zhong C, Zhu Z, Zheng X, Yang P, Che B, Lu Y, Zhang Y, Xu T. Plasma Human Cartilage Glycoprotein-39 and Cognitive Impairment After Acute Ischemic Stroke. J Am Heart Assoc. 2025 Jan 21;14(2):e036790. doi: 10.1161/JAHA.124.036790. Epub 2025 Jan 17.
Reference Type
DERIVED
He Y, Jia Y, Liu Y, Chang X, Yang P, Shi M, Guo D, Peng Y, Chen J, Wang A, Xu T, He J, Zhang Y, Zhu Z. High Plasma Polyamine Levels Are Associated With an Increased Risk of Poststroke Cognitive Impairment: A Multicenter Prospective Study From CATIS. J Am Heart Assoc. 2025 Jan 21;14(2):e037465. doi: 10.1161/JAHA.124.037465. Epub 2025 Jan 16.
Reference Type
DERIVED
Sun L, Zhang Q, Shi M, Liu Y, Zhu Z, Zhang J, Peng H, Wang A, Chen J, Xu T, Zhang Y, He J. Associations Between Gene Variants of Lipid-Lowering Drug Targets and Adverse Outcomes After Ischemic Stroke. J Am Heart Assoc. 2024 Nov 19;13(22):e036544. doi: 10.1161/JAHA.124.036544. Epub 2024 Nov 15.
Reference Type
DERIVED
Yang P, Shi M, Jia Y, Zhong C, Peng H, Sun L, Guo D, Chen J, Wang A, Xu T, Zhu Z, Zhang Y, He J. Plasma Polyamines and Short-Term Adverse Outcomes Among Patients With Ischemic Stroke: A Prospective Cohort Study. J Am Heart Assoc. 2024 Aug 6;13(15):e035837. doi: 10.1161/JAHA.124.035837. Epub 2024 Jul 31.
Reference Type
DERIVED
Wang Z, Zhang K, Zhong C, Zhu Z, Zheng X, Yang P, Che B, Lu Y, Zhang Y, Xu T. Alcohol drinking modified the effect of plasma YKL-40 levels on stroke-specific mortality of acute ischemic stroke. Neuroscience. 2024 Aug 6;552:152-158. doi: 10.1016/j.neuroscience.2024.06.028. Epub 2024 Jun 27.
Reference Type
DERIVED
Yang P, Wang S, Zhong C, Yin J, Yang J, Wang A, Xu T, Zhang Y. Association of Cardiac Biomarkers in Combination With Cognitive Impairment After Acute Ischemic Stroke. J Am Heart Assoc. 2024 Mar 5;13(5):e031010. doi: 10.1161/JAHA.123.031010. Epub 2024 Feb 23.
Reference Type
DERIVED
Du J, Zhai Y, Dong W, Che B, Miao M, Peng Y, Ju Z, Xu T, He J, Zhang Y, Zhong C. One-Year Disability Trajectories and Long-Term Cardiovascular Events, Recurrent Stroke, and Mortality After Ischemic Stroke. J Am Heart Assoc. 2024 Feb 6;13(3):e030702. doi: 10.1161/JAHA.123.030702. Epub 2024 Jan 19.
Reference Type
DERIVED
Zhai Y, Chen H, Che B, Liu Y, Peng Y, Chen J, Xu T, He J, Zhang Y, Zhong C. Efficacy of Immediate Antihypertensive Treatment in Patients With Acute Ischemic Stroke With Different Blood Pressure Genetic Variants. Hypertension. 2024 Mar;81(3):658-667. doi: 10.1161/HYPERTENSIONAHA.123.21851. Epub 2024 Jan 4.
Reference Type
DERIVED
Zhai Y, Shi M, Liu Y, Peng Y, Zhu Z, Wang A, Peng H, Xu T, Chen J, Xu T, Zhang Y, He J, Zhong C. Magnitude of Systolic Blood Pressure Reduction and Early Achieved Blood Pressure and Clinical Outcomes After Acute Ischemic Stroke. J Am Heart Assoc. 2023 Oct 17;12(20):e030692. doi: 10.1161/JAHA.123.030692. Epub 2023 Oct 7.
Reference Type
DERIVED
Zhu Z, Yang P, Jia Y, Wang Y, Shi M, Zhong C, Peng H, Sun L, Guo D, Xu Q, Chen J, Wang A, Xu T, He J, Zhang Y. Plasma Amino Acid Neurotransmitters and Ischemic Stroke Prognosis: A Multicenter Prospective Study. Am J Clin Nutr. 2023 Oct;118(4):754-762. doi: 10.1016/j.ajcnut.2023.06.014. Epub 2023 Aug 21.
Reference Type
DERIVED
Zhu Z, Guo D, Zhang K, Yang P, Jia Y, Shi M, Peng Y, Chen J, Wang A, Xu T, Zhang Y, He J. Osteoprotegerin and Ischemic Stroke Prognosis: A Prospective Multicenter Study and Mendelian Randomization Analysis. Stroke. 2023 Feb;54(2):509-517. doi: 10.1161/STROKEAHA.122.040800. Epub 2022 Dec 13.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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140815
Identifier Type: -
Identifier Source: org_study_id
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