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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
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Ji Man Hong, 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Ischemic Stroke Drug: Fimasartan Drug: Valsartan Drug: Atenolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fimasartan
fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
Drug: Fimasartan
Other Name: kanarb

Active Comparator: Valsartan
valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
Drug: Valsartan
Other Name: Diovan

Active Comparator: Atenolol
atenolol 50mg, 1 tablet by mouth, every day beta-blocker
Drug: Atenolol
Other Name: tenormin




Primary Outcome Measures :
  1. Central Blood pressure control [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Blood pressure at the brachial artery [ Time Frame: 12 weeks ]
  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. Adverse Events [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications of Results:
NAVIGATOR Study Group, McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamás G, Tognoni G, Tuomilehto J, Villamil AS, Vozár J, Califf RM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1477-90. doi: 10.1056/NEJMoa1001121. Epub 2010 Mar 14. Erratum in: N Engl J Med. 2010 May 6;362(18):1748.

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Responsible Party: Ji Man Hong, Associate Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02403349     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-12-049-HJM
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Valsartan
Atenolol
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents