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China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)

This study has been completed.
Sponsor:
Collaborator:
Soochow University
Information provided by (Responsible Party):
Jiang He, MD, PhD, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01840072
First received: April 13, 2013
Last updated: September 2, 2016
Last verified: September 2016
Results First Received: November 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Other: Active antihypertensive treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Active Antihypertensive Treatment   Usual Care
STARTED   2038   2033 
COMPLETED   2031   1986 
NOT COMPLETED   7   47 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Active Antihypertensive Treatment   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 2038   2033   4071 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.1  (10.8)   61.8  (11.0)   62.0  (10.9) 
Gender 
[Units: Participants]
     
Female   1317   1287   2604 
Male   721   746   1467 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   2038   2033   4071 
Region of Enrollment 
[Units: Participants]
     
China   2038   2033   4071 


  Outcome Measures
  Show All Outcome Measures

1.  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.   [ Time Frame: 2 weeks ]

2.  Secondary:   Mortality   [ Time Frame: 3, 12, and 24 months ]

3.  Secondary:   Recurrent Stroke   [ Time Frame: 3, 12 and 24 months ]

4.  Secondary:   Other Vascular Events   [ Time Frame: 3, 12 and 24 months ]

5.  Secondary:   A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Long-term Neurological and Functional Status   [ Time Frame: 3, 12 and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Cognitive Function   [ Time Frame: 3, 12 and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Quality of Life   [ Time Frame: 3, 12 and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: jhe@tulane.edu


Publications of Results:

Responsible Party: Jiang He, MD, PhD, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01840072     History of Changes
Other Study ID Numbers: 140815
Study First Received: April 13, 2013
Results First Received: November 13, 2014
Last Updated: September 2, 2016
Health Authority: United States: Institutional Review Board
China: Institutional Review Board