Blood Pressure, Ischemic Stroke
Conditions
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.
Interventions
DRUGFimasartan
DRUGValsartan
DRUGAtenolol
Sponsors
Boryung Pharmaceutical Co., Ltd
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Blood pressure control | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Blood pressure at the brachial artery | 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). |
| Adverse Events | 12 weeks | — |
| 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). |
Outcome results
None listed