Trial Outcomes & Findings for China Antihypertensive Trial in Acute Ischemic Stroke (NCT NCT01840072)

NCT ID: NCT01840072

Last Updated: 2024-03-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4071 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2024-03-27

Participant Flow

Participant milestones

Measure	Active Antihypertensive Treatment 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.	Usual Care Discontinue all home BP medications.
Overall Study STARTED	2038	2033
Overall Study COMPLETED	2031	1986
Overall Study NOT COMPLETED	7	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

China Antihypertensive Trial in Acute Ischemic Stroke

Baseline characteristics by cohort

Measure	Active Antihypertensive Treatment n=2038 Participants 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.	Usual Care n=2033 Participants Discontinue all home BP medications.	Total n=4071 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 10.8 • n=5 Participants	61.8 years STANDARD_DEVIATION 11.0 • n=7 Participants	62.0 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	1317 Participants n=5 Participants	1287 Participants n=7 Participants	2604 Participants n=5 Participants
Sex: Female, Male Male	721 Participants n=5 Participants	746 Participants n=7 Participants	1467 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2038 participants n=5 Participants	2033 participants n=7 Participants	4071 participants n=5 Participants
Region of Enrollment China	2038 participants n=5 Participants	2033 participants n=7 Participants	4071 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Measure	Active Antihypertensive Treatment n=2033 Participants 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.	Usual Care n=2038 Participants Discontinue all home BP medications.
A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.	681 participants	683 participants

SECONDARY outcome

Timeframe: 3 months

Population: All participants examined at 3-month posttreatment follow-up visit

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

Outcome measures

Measure	Active Antihypertensive Treatment n=1987 Participants 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.	Usual Care n=1988 Participants Discontinue all home BP medications.
A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.	502 Participants	500 Participants

SECONDARY outcome

Timeframe: 3 months

Population: All participants followed at 3-month posttreatment follow-up visit

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.

Outcome measures

Measure	Active Antihypertensive Treatment n=1988 Participants 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.	Usual Care n=1987 Participants Discontinue all home BP medications.
Mortality	68 participants	54 participants

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Active Antihypertensive Treatment n=1988 Participants 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.	Usual Care n=1987 Participants Discontinue all home BP medications.
Recurrent Stroke	28 participants	43 participants

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Active Antihypertensive Treatment n=1987 Participants 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.	Usual Care n=1988 Participants Discontinue all home BP medications.
Other Vascular Events	59 participants	48 participants

SECONDARY outcome

Timeframe: Three months

Population: Those patients who are still alive and followed at 3-Month posttreatment follow-up visit

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.

Outcome measures

Measure	Active Antihypertensive Treatment n=1987 Participants 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.	Usual Care n=1988 Participants Discontinue all home BP medications.
Long-term Neurological and Functional Status	1.0 Score on modified Rankin scale Interval 1.0 to 3.0	1.0 Score on modified Rankin scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Three months

Population: 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.

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).

Outcome measures

Measure	Active Antihypertensive Treatment n=324 Participants 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.	Usual Care n=314 Participants Discontinue all home BP medications.
Cognitive Function (the Mini-Mental State Examination)	26 MMSE score Interval 22.0 to 29.0	26 MMSE score Interval 22.0 to 29.0

SECONDARY outcome

Timeframe: Three months

Population: 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.

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.

Outcome measures

Measure	Active Antihypertensive Treatment n=324 Participants 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.	Usual Care n=314 Participants Discontinue all home BP medications.
Cognitive Function (Montreal Cognitive Assessment)	22 MoCA score Interval 18.0 to 26.0	22 MoCA score Interval 18.0 to 26.0

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome data not reported

Adverse Events

Active Antihypertensive Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jiang He

Tulane University

Phone: 5049885165

Email: jhe@tulane.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place