Clinical trial NCT02403349: Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
Official title: Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Blood Pressure
Ischemic Stroke
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2015-03-31
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Central Blood pressure control
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood pressure at the brachial artery
timeFrame: 12 weeks
measure: Brachial-ankle pulse wave velocity (ba-PWV)
timeFrame: 12 weeks
measure: Flow-mediated dilation (FMD)
timeFrame: 12 weeks
measure: Pulsatile index (PI)
timeFrame: 12 weeks
measure: Cerebral blood flow (CBF) volume
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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