Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol (FAVOR)
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|ClinicalTrials.gov Identifier: NCT02403349|
Recruitment Status : Unknown
Verified March 2015 by Ji Man Hong, Ajou University School of Medicine.
Recruitment status was: Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Ajou University School of Medicine
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Ji Man Hong, Ajou University School of Medicine
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.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Ischemic Stroke||Drug: Fimasartan Drug: Valsartan Drug: Atenolol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||September 2015|
fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
Other Name: kanarb
Active Comparator: Valsartan
valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
Other Name: Diovan
Active Comparator: Atenolol
atenolol 50mg, 1 tablet by mouth, every day beta-blocker
Other Name: tenormin
Primary Outcome Measures :
- Central Blood pressure control [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- Blood pressure at the brachial artery [ Time Frame: 12 weeks ]
- Brachial-ankle pulse wave velocity (ba-PWV) [ Time Frame: 12 weeks ]Ba-PWV is measured using ABI/PWV (VP-2000; Colin). This device has four cuffs that can be used to simultaneously measure blood pressure in both arms and both legs, and automatically calculate the ABI. It also records pulse waves with the sensors in the cuffs, computes the difference between transmission time in the arm and transmission time in the ankle, calculates the transmission distance from the right arm to each ankle according to body height, and thus computes the ba-PWV values from the transmission time and transmission distance.
- Flow-mediated dilation (FMD) [ Time Frame: 12 weeks ]FMD is measured as the brachial artery diameters at baseline and at maximum dilation after forearm ischemia for 5 minutes. FMD is calculated as the percentage of postischemic dilation.
- Pulsatile index (PI) [ Time Frame: 12 weeks ]We analyze the change of PIs in the middle cerebral artery at baseline and 90 Days on transcranial Doppler (TCD) Study in the same patient. The PI is automatically calculated on the TCD machine (PMD 150, Sphencer technologies, USA).
- Cerebral blood flow (CBF) volume [ Time Frame: 12 weeks ]CBF volume is measured by color-coded duplex sonography measuring total flow volumes of the internal carotid artery (ICAs) and vertebral artery (VAs).
- Adverse Events [ Time Frame: 12 weeks ]
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