NCT01840072

Brief Summary

This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,071

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 20, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

3.8 years

First QC Date

April 13, 2013

Results QC Date

November 13, 2014

Last Update Submit

March 21, 2024

Conditions

Ischemic Stroke

Keywords

Ischemic strokeHypertensionAntihypertensive AgentsRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.

    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 Outcomes (8)

  • A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.

    3 months

  • Mortality

    3 months

  • Recurrent Stroke

    3 months

  • Other Vascular Events

    3 months

  • Long-term Neurological and Functional Status

    Three months

  • +3 more secondary outcomes

Study Arms (2)

Active antihypertensive treatment

EXPERIMENTAL

Active antihypertensive treatment

Other: Active antihypertensive treatment

Usual care

NO INTERVENTION

Discontinue all home BP medications.

Interventions

Active antihypertensive treatmentOTHER

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.

Active antihypertensive treatment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soohow University

Suzhou, Jiangsu, 215123, China

Location

Related Publications (31)

  • 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.

    PMID: 27110711RESULT

  • 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.

    PMID: 26910818RESULT

  • 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.

    PMID: 24240777RESULT

  • 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.

    PMID: 27412188RESULT

  • Zhong C, Wang M, Liu D, Wei Y, Wang M, Peng Y, Chen J, Pan Y, Xu T, Wang Y, He J, Wang Y, Zhang Y, Liu L, Xie X. Antihypertensive Treatments After Acute Ischemic Stroke: to Continue or Not? Hypertension. 2026 Feb;83(2):e25575. doi: 10.1161/HYPERTENSIONAHA.125.25575. Epub 2025 Dec 5.

    PMID: 41347304DERIVED

  • 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.

    PMID: 40847526DERIVED

  • 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 Dec 23;10(6):743-751. doi: 10.1136/svn-2024-003896.

    PMID: 40268338DERIVED

  • 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.

    PMID: 40068363DERIVED

  • 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.

    PMID: 39819010DERIVED

  • 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.

    PMID: 39817544DERIVED

  • 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.

    PMID: 39547981DERIVED

  • 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.

    PMID: 39082415DERIVED

  • 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.

    PMID: 38944147DERIVED

  • 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.

    PMID: 38390800DERIVED

  • 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.

    PMID: 38240201DERIVED

  • 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.

    PMID: 38174564DERIVED

  • 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.

    PMID: 37804202DERIVED

  • 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.

    PMID: 37793742DERIVED

  • 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.

    PMID: 36511149DERIVED

  • 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.

    PMID: 36353999DERIVED

  • 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.

    PMID: 36155150DERIVED

  • 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.

    PMID: 36102255DERIVED

  • 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.

    PMID: 34493532DERIVED

  • 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.

    PMID: 34159355DERIVED

  • 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.

    PMID: 32779506DERIVED

  • 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.

    PMID: 32233741DERIVED

  • 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.

    PMID: 31719258DERIVED

  • 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.

    PMID: 31365109DERIVED

  • 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.

    PMID: 30852966DERIVED

  • 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.

    PMID: 29389742DERIVED

  • 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.

    PMID: 28169880DERIVED

MeSH Terms

Conditions

Ischemic StrokeHypertension

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Jiang He
Organization
Tulane University
jhe@tulane.edu
5049885165

Study Officials

  • Jiang He, MD, PhD

    Tulane University SPHTM

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Department Chair

Study Record Dates

First Submitted

April 13, 2013

First Posted

April 25, 2013

Study Start

August 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2016

Last Updated

March 27, 2024

Results First Posted

November 20, 2014

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)