Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol

Phase 4

• Conditions: Blood Pressure; Ischemic Stroke
• Interventions: Drug: Fimasartan; Drug: Valsartan; Drug: Atenolol

• Registration Number: NCT02403349
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Status Verified: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-26
• Last Update Submitted: 2015-03-26
• Study First Posted: 2015-03-31
• Last Update Posted: 2015-03-31
• Primary Completion: 2015-05
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fimasartan	Fimasartan	fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
Valsartan	Valsartan	valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
Atenolol	Atenolol	atenolol 50mg, 1 tablet by mouth, every day beta-blocker

Primary Outcome Measures

Name	Time	Method
Central Blood pressure control	12 weeks

Secondary Outcome Measures

Name	Time	Method
Blood pressure at the brachial artery	12 weeks
Flow-mediated dilation (FMD)	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.
Adverse Events	12 weeks
Cerebral blood flow (CBF) volume	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).
Brachial-ankle pulse wave velocity (ba-PWV)	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.
Pulsatile index (PI)	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).