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

Ajou University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Ischemic Stroke; Blood Pressure

Treatments: Drug: Atenolol; Drug: Valsartan; Drug: Fimasartan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02403349

AJIRB-MED-CT4-12-049-HJM

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups

Fimasartan

Experimental group

Description:

fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker

Treatment:

Drug: Fimasartan

Valsartan

Active Comparator group

Description:

valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists

Treatment:

Drug: Valsartan

Atenolol

Active Comparator group

Description:

atenolol 50mg, 1 tablet by mouth, every day beta-blocker

Treatment:

Drug: Atenolol