China Antihypertensive Trial in Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— CATIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840072
• Other study ID #: 140815
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: May 2016

Study information

• Verified date: March 2024
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4071
• Est. completion date: May 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Soohow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	Soochow University

Country where clinical trial is conducted

China, 

References & Publications (4)

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; — View Citation

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):1009-101 — View Citation

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 bl — View Citation

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 Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	Three months
Secondary	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).	Three months
Secondary	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.	Three months
Secondary	Quality of Life	Due to limited funding, quality of life data were not collected.	3 months