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

March 26, 2015 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fimasartan
fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
Drug: Fimasartan
Other Names:
  • kanarb
Active Comparator: Valsartan
valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
Drug: Valsartan
Other Names:
  • Diovan
Active Comparator: Atenolol
atenolol 50mg, 1 tablet by mouth, every day beta-blocker
Drug: Atenolol
Other Names:
  • tenormin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central Blood pressure control
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 weeks
12 weeks
Blood pressure at the brachial artery
Time Frame: 12 weeks
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.
12 weeks
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.
12 weeks
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).
12 weeks
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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Collaborators

Boryung Pharmaceutical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT4-12-049-HJM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on Valsartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe