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| Name | Class |
|---|---|
| Soochow University | OTHER |
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This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active antihypertensive treatment | Experimental | Active antihypertensive treatment |
|
| Usual care | No Intervention | Discontinue all home BP medications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active antihypertensive treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang He, MD, PhD | Tulane University SPHTM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soohow University | Suzhou | Jiangsu | 215123 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27110711 | Result | 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. | |
| 26910818 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Discontinue all home BP medications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 2 weeks |
|
14 days, 3 months, 12 months, and 24 months
No serious or other (non-serious) adverse events were observed for any participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jiang He | Tulane University | 5049885165 | jhe@tulane.edu |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 3 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Quality of Life | Due to limited funding, quality of life data were not collected. | 3 months |
| 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. |
| 24240777 | Result | 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. |
| 27412188 | Result | 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. |
| 42374230 | Derived | 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. |
| 41347304 | Derived | 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. |
| 40847526 | Derived | 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. |
| 40268338 | Derived | 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. |
| 40068363 | Derived | 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. |
| 39819010 | Derived | 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. |
| 39817544 | Derived | 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. |
| 39547981 | Derived | 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. |
| 39082415 | Derived | 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. |
| 38944147 | Derived | 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. |
| 38390800 | Derived | 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. |
| 38240201 | Derived | 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. |
| 38174564 | Derived | 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. |
| 37804202 | Derived | 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. |
| 37793742 | Derived | 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. |
| 36511149 | Derived | 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. |
| 36353999 | Derived | 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. |
| 36155150 | Derived | 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. |
| 36102255 | Derived | 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. |
| 34493532 | Derived | 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. |
| 34159355 | Derived | 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. |
| 32779506 | Derived | 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. |
| 32233741 | Derived | 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. |
| 31719258 | Derived | 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. |
| 31365109 | Derived | 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. |
| 30852966 | Derived | 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. |
| 29389742 | Derived | 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. |
| 28169880 | Derived | 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. |
| BG001 | Usual Care | Discontinue all home BP medications. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | All participants examined at 3-month posttreatment follow-up visit | Posted | Count of Participants | Participants | 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. | All participants followed at 3-month posttreatment follow-up visit | Posted | Number | participants | 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. | Posted | Number | participants | 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. | Posted | Number | participants | 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. | Those patients who are still alive and followed at 3-Month posttreatment follow-up visit | Posted | Median | Inter-Quartile Range | Score on 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). | 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. | Posted | Median | Inter-Quartile Range | MMSE score | 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. | 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. | Posted | Median | Inter-Quartile Range | MoCA score | Three months |
|
|
|
| Secondary | Quality of Life | Due to limited funding, quality of life data were not collected. | Posted | 3 months |
|
|
| 0 |
| 2,038 |
| 0 |
| 2,038 |
| EG001 | Usual Care | Discontinue all home BP medications. | 0 | 2,033 | 0 | 2,033 |
Not provided
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |