Status:
COMPLETED
China Antihypertensive Trial in Acute Ischemic Stroke II
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Beijing Tiantan Hospital
Soochow University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The investigators propose to conduct a multicenter randomized trial to test the primary hypothesis of whether early antihypertensive treatment starting between the first 24-48 hours after the onset of...
Detailed Description
Stroke is the leading cause of death in China and the second leading cause of death in the world. In addition, stroke is the leading cause of long-term disability worldwide and a major financial burde...
Eligibility Criteria
Inclusion
- Men and women aged ≥40 years
- Acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) of the head
- Stroke onset within 24-48 hours\*
- Systolic blood pressure between 140-200 mmHg and diastolic blood pressure between 80-120 mmHg
Exclusion
- Hemorrhagic stroke confirmed by CT or MRI of the head
- CT or MRI-diagnosed vascular malformation, tumor, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis)
- Extracranial or intracranial artery stenosis (≥70%) in both sides or the affected side based on imagine study
- Stroke caused by arteritis, migraine, vasospasm, or substance abuse
- Severe stroke (NIHSS score of ≥21)
- Coma (Glasgow Coma Scale \[GCS\] score \<8)
- Preceding moderate or severe dependency (modified Rankin scale \[mRS\] score 3-5)
- Planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening
- Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy
- Severe heart failure (NY Heart Association class III and IV) or left ventricular ejection fraction \<35%
- Myocardial infarction or unstable angina within past 3 months
- History of atrial fibrillation.
- History of aortic dissection
- History of all-cause dementia
- Difficult-to-control hypertension (systolic blood pressure ≥170 mmHg despite use of ≥4 antihypertensive medications for ≥6 months)
- Acute renal failure or dialysis or estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73 m2
- Any clinical conditions judged by the clinic team to likely limit the adherence to study procedures
- Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
- Unable to participate in the follow-up examination (e.g., cannot travel to the participating hospital)
- Participation in another clinical trial within 30 days
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control
- Failure to obtain informed consent from a participant
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2023
Estimated Enrollment :
4810 Patients enrolled
Trial Details
Trial ID
NCT03479554
Start Date
June 13 2018
End Date
January 15 2023
Last Update
August 1 2023
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050