China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)

This study is ongoing, but not recruiting participants.
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 12, 2013
Last verified: September 2013
  Purpose

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

Condition Intervention
Ischemic Stroke
Other: Active antihypertensive treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inner Mongolia Stroke Project

Resource links provided by NLM:


Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    The assessment using the modified Rankin scale will be obtained on 14 day after the randomization or at the hospital discharge.

  • Neurological dysfunction (NIH Stroke Scale, NIHSS) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Neurological dysfunction assessment using NIHSS will be obtained on 14 day after the randomization or at the hospital discharge.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 3, 12, and 24 months ] [ Designated as safety issue: No ]
    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.

  • Recurrent stroke [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    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.

  • Other vascular events [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    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.

  • Long-term neurological and functional status [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Neurological and functional assessments including the modified Rankin scale and NIHSS will be performed.

  • Cognitive function [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. The information on the cognitive function will be obtained.

  • Quality of life [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. The information on the quality of life will be obtained.


Enrollment: 4071
Study Start Date: August 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active antihypertensive treatment
Active antihypertensive treatment
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.
No Intervention: Usual care
Discontinue all home BP medications.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840072

Locations
China, Jiangsu
Soohow University
Suzhou, Jiangsu, China, 215123
Sponsors and Collaborators
Tulane University Health Sciences Center
Soochow University
Investigators
Principal Investigator: Jiang He, MD, PhD Tulane University SPHTM
  More Information

No publications provided by Tulane University Health Sciences Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jiang He, MD, PhD, Professor and Department Chair, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01840072     History of Changes
Other Study ID Numbers: 140815
Study First Received: April 13, 2013
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board
China: Institutional Review Board

Keywords provided by Tulane University Health Sciences Center:
Ischemic stroke
Hypertension
Antihypertensive Agents
Randomized Controlled Trial

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Membrane Transport Modulators

ClinicalTrials.gov processed this record on July 26, 2014