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China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)

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ClinicalTrials.gov Identifier: NCT01840072
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : November 20, 2014
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Soochow University
Information provided by (Responsible Party):
Jiang He, MD, PhD, Tulane University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ischemic Stroke
Intervention Other: Active antihypertensive treatment
Enrollment 4071

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Antihypertensive Treatment Usual Care
Hide Arm/Group Description

Active antihypertensive treatment

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.

Discontinue all home BP medications.
Period Title: Overall Study
Started 2038 2033
Completed 2031 1986
Not Completed 7 47
Arm/Group Title Active Antihypertensive Treatment Usual Care Total
Hide Arm/Group Description

Active antihypertensive treatment

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.

Discontinue all home BP medications. Total of all reporting groups
Overall Number of Baseline Participants 2038 2033 4071
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2038 participants 2033 participants 4071 participants
62.1  (10.8) 61.8  (11.0) 62.0  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2038 participants 2033 participants 4071 participants
Female
1317
  64.6%
1287
  63.3%
2604
  64.0%
Male
721
  35.4%
746
  36.7%
1467
  36.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 2038 participants 2033 participants 4071 participants
2038 2033 4071
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 2038 participants 2033 participants 4071 participants
2038 2033 4071
1.Primary Outcome
Title A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.
Hide Description 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.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 2033 2038
Measure Type: Number
Unit of Measure: participants
681 683
2.Secondary Outcome
Title A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.
Hide Description 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
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants examined at 3-month posttreatment follow-up visit
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 1987 1988
Measure Type: Count of Participants
Unit of Measure: Participants
502
  25.3%
500
  25.2%
3.Secondary Outcome
Title Mortality
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants followed at 3-month posttreatment follow-up visit
Arm/Group Title Active Antihypertensive Treatment Usual Care
Hide Arm/Group Description:

Active antihypertensive treatment

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.

Discontinue all home BP medications.
Overall Number of Participants Analyzed 1988 1987
Measure Type: Number
Unit of Measure: participants
68 54
4.Secondary Outcome
Title Recurrent Stroke
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Antihypertensive Treatment Usual Care
Hide Arm/Group Description:

Active antihypertensive treatment

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.

Discontinue all home BP medications.
Overall Number of Participants Analyzed 1988 1987
Measure Type: Number
Unit of Measure: participants
28 43
5.Secondary Outcome
Title Other Vascular Events
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 1987 1988
Measure Type: Number
Unit of Measure: participants
59 48
6.Secondary Outcome
Title Long-term Neurological and Functional Status
Hide Description 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.
Time Frame Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Those patients who are still alive and followed at 3-Month posttreatment follow-up visit
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 1987 1988
Median (Inter-Quartile Range)
Unit of Measure: Score on modified Rankin scale
1.0
(1.0 to 3.0)
1.0
(1.0 to 3.0)
7.Secondary Outcome
Title Cognitive Function (the Mini-Mental State Examination)
Hide Description 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).
Time Frame Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 324 314
Median (Inter-Quartile Range)
Unit of Measure: MMSE score
26
(22 to 29)
26
(22 to 29)
8.Secondary Outcome
Title Cognitive Function (Montreal Cognitive Assessment)
Hide Description 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.
Time Frame Three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 324 314
Median (Inter-Quartile Range)
Unit of Measure: MoCA score
22
(18 to 26)
22
(18 to 26)
9.Secondary Outcome
Title Quality of Life
Hide Description Due to limited funding, quality of life data were not collected.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Active Antihypertensive Treatment
Hide Arm/Group Description:
Discontinue all home BP medications.

Active antihypertensive treatment

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 14 days, 3 months, 12 months, and 24 months
Adverse Event Reporting Description No serious or other (non-serious) adverse events were observed for any participants.
 
Arm/Group Title Active Antihypertensive Treatment Usual Care
Hide Arm/Group Description

Active antihypertensive treatment

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.

Discontinue all home BP medications.
All-Cause Mortality
Active Antihypertensive Treatment Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Antihypertensive Treatment Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2038 (0.00%)   0/2033 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Antihypertensive Treatment Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2038 (0.00%)   0/2033 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jiang He
Organization: Tulane University
Phone: 5049885165
Responsible Party: Jiang He, MD, PhD, Tulane University
ClinicalTrials.gov Identifier: NCT01840072     History of Changes
Other Study ID Numbers: 140815
First Submitted: April 13, 2013
First Posted: April 25, 2013
Results First Submitted: November 13, 2014
Results First Posted: November 20, 2014
Last Update Posted: April 25, 2017