Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
NCT ID: NCT02403349
Last Updated: 2015-03-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
105 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-05-31
Study Completion Date
2015-09-30
Brief Summary
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Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and compare correlation with the measured peripheral (central blood pressure, pulse wave velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.
Detailed Description
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Conditions
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Blood Pressure
Ischemic Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Fimasartan
fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
Group Type
EXPERIMENTAL
Fimasartan
Intervention Type
DRUG
Valsartan
valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
Group Type
ACTIVE_COMPARATOR
Valsartan
Intervention Type
DRUG
Atenolol
atenolol 50mg, 1 tablet by mouth, every day beta-blocker
Group Type
ACTIVE_COMPARATOR
Atenolol
Intervention Type
DRUG
Interventions
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Fimasartan
Intervention Type
DRUG
Valsartan
Intervention Type
DRUG
Atenolol
Intervention Type
DRUG
Other Intervention Names
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kanarb
Diovan
tenormin
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 30 years old
* Acute ischemic stroke patient who has corresponding DWI(diffusion- weighted imaging) lesion correlated with symptom
* after 7days, but within 28days from stroke onset
* Diagnosed with Hypertension
* hypertensive patients who taking anti-hypertensive drugs or SBP≥140mmHg
* Informed consent
* Acute ischemic stroke patient who has corresponding DWI(diffusion- weighted imaging) lesion correlated with symptom
* after 7days, but within 28days from stroke onset
* Diagnosed with Hypertension
* hypertensive patients who taking anti-hypertensive drugs or SBP≥140mmHg
* Informed consent
Exclusion Criteria
* Patients with hemorrhagic Stroke
* Patients with severe Stroke - over NIHss(National Institutes of Health stroke scale) 16
* Uncontrolled hypertension (SBP ≥200mmHg)
* Patients with history of allergic reaction to any angiotensin II antagonist
* Liver disease(more than double to normal level, SGOT(serum glutamic-oxaloacetic transaminase ), SGPT(serum glutamic-pyruvic transaminase ), total bilirubin)
* Renal disease(serum creatinine ≥2.0mg/dl)
* Anemia(Hb \< 8mg/dl)
* Thrombocytopenia( \< 10\^3/ml)
* Patients with secondary hypertension
* Childbearing and breast-feeding women
* Otherwise inappropriate patients depending on the investigator's decision
* Patients with severe Stroke - over NIHss(National Institutes of Health stroke scale) 16
* Uncontrolled hypertension (SBP ≥200mmHg)
* Patients with history of allergic reaction to any angiotensin II antagonist
* Liver disease(more than double to normal level, SGOT(serum glutamic-oxaloacetic transaminase ), SGPT(serum glutamic-pyruvic transaminase ), total bilirubin)
* Renal disease(serum creatinine ≥2.0mg/dl)
* Anemia(Hb \< 8mg/dl)
* Thrombocytopenia( \< 10\^3/ml)
* Patients with secondary hypertension
* Childbearing and breast-feeding women
* Otherwise inappropriate patients depending on the investigator's decision
Minimum Eligible Age
30 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Sponsor Role
collaborator
Ajou University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Ji Man Hong
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
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Other Identifiers
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AJIRB-MED-CT4-12-049-HJM
Identifier Type: -
Identifier Source: org_study_id