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Completed

NCT Number: NCT01840072

China Antihypertensive Trial in Acute Ischemic Stroke

This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypertension Nervous System Diseases Stroke Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soohow University

Suzhou, Jiangsu, 215123, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.

    Time frame: 3 months

    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

  2. Mortality

    Time frame: 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 on clinical deaths will be obtained.

  3. Recurrent Stroke

    Time frame: 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.

  4. Other Vascular Events

    Time frame: 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.

  5. Long-term Neurological and Functional Status

    Time frame: Three months

    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.

  6. Cognitive Function (the Mini-Mental State Examination)

    Time frame: Three months

    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).

  7. Cognitive Function (Montreal Cognitive Assessment)

    Time frame: Three months

    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.

  8. Quality of Life

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Soochow University

Registry information

Official study title

Inner Mongolia Stroke Project A Randomized Controlled Trial of Immediate Blood Pressure Reduction on Death and Major Disability in Patients With Acute Ischemic Stroke in China

Acronym: CATIS

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
Apr 25, 2013
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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