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Ischemic StrokeCATISNCT01840072

China Antihypertensive Trial in Acute Ischemic Stroke

A study testing Active antihypertensive treatment in people with Ischemic Stroke, run by Tulane University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Active antihypertensive treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,071 participants
Where
1 siteChina
Study dates
Aug 2009to May 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Soohow University

    Suzhou, Jiangsu, 215123

Other trials in China

About this study

Official title: 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.

Read the 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
Conditions
Ischemic Stroke
Being tested
Active antihypertensive treatment
Keywords
Ischemic stroke, Hypertension, Antihypertensive Agents, Randomized Controlled Trial
Medical subject headings
Ischemic Stroke, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01840072
Study groupRoleWhat they receive
Active antihypertensive treatmentExperimentalActive antihypertensive treatment
Receives: Other: Active antihypertensive treatment
Usual careNo interventionDiscontinue all home BP medications.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 weeks

Secondary outcomes (8)
  1. A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.

    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

    Measured: 3 months

  2. Mortality

    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.

    Measured: 3 months

  3. Recurrent Stroke

    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.

    Measured: 3 months

  4. Other Vascular Events

    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.

    Measured: 3 months

  5. Long-term Neurological and Functional Status

    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.

    Measured: Three months

  6. Cognitive Function (the Mini-Mental State Examination)

    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).

    Measured: Three months

  7. Cognitive Function (Montreal Cognitive Assessment)

    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.

    Measured: Three months

  8. Quality of Life

    Due to limited funding, quality of life data were not collected.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2013
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
4,071 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01840072
Sponsor's protocol ID
140815
Acronym
CATIS
Status last verified
Mar 2024
First submitted
13 Apr 2013
Last updated
27 Mar 2024
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 27110711
  • 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.

    PubMed 26910818
  • 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.

    PubMed 24240777
  • 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.

    PubMed 27412188
  • Qin S, Wang M, Zhu Y, Wu S, Du M, Peng Y, Xu T, Zhang Y, Xu X, Zhong C, Xiao G. Plasma Glutamine and Glutamate in Relation to Clinical Outcomes After Ischemic Stroke: A Multicenter Prospective Study. J Am Heart Assoc. 2026 Oct 10:e049903. doi: 10.1161/JAHA.126.049903. Online ahead of print.

    PubMed 42858005
  • Zhao W, Sun L, Zan J, Zheng X, Zhou J, Yang X, Zhang Y, Shi M, Xu T. Plasma Cluster of Differentiation 147 and Cognitive Impairment After Acute Ischemic Stroke. J Am Heart Assoc. 2026 Sep 9:e048033. doi: 10.1161/JAHA.125.048033. Online ahead of print.

    PubMed 42714478
  • Yang P, Sun L, Jia Y, Zhu Z, Wang A, Zhang Y, Xu T, Su L. Serum S100B and Its Interplay With hs-CRP and Platelet Count in Association With Adverse Outcomes After Ischemic Stroke. J Am Heart Assoc. 2026 Aug 20:e048160. doi: 10.1161/JAHA.125.048160. Online ahead of print.

    PubMed 42622219
  • Zong Z, Zhou C, Guo H, Cao M, Wu S, Xu T, Zhang Y, Zhong C, Liu H. Plasma choline and betaine and neurological function trajectory after acute ischemic stroke. BMC Neurol. 2026 Jun 30. doi: 10.1186/s12883-026-05132-9. Online ahead of print.

    PubMed 42374230
  • 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.

    PubMed 41347304
  • 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.

    PubMed 40847526
  • 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.

    PubMed 40268338
  • 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.

    PubMed 40068363
  • 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.

    PubMed 39819010
  • 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.

    PubMed 39817544
  • 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.

    PubMed 39547981

Questions about this trial

What is this clinical trial studying?

A study testing Active antihypertensive treatment in people with Ischemic Stroke, run by Tulane University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01840072, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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