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

Ischemic Stroke Clinical Trial

— FAVOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02403349
• Other study ID #: AJIRB-MED-CT4-12-049-HJM
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 12, 2015
• Last updated: March 26, 2015
• Start date: May 2012
• Est. completion date: September 2015

Study information

• Verified date: March 2015
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Fimasartan

• Valsartan

• Atenolol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Boryung Pharmaceutical Co., Ltd

References & Publications (25)

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and — View Citation

Dhakam Z, McEniery CM, Yasmin, Cockcroft JR, Brown MJ, Wilkinson IB. Atenolol and eprosartan: differential effects on central blood pressure and aortic pulse wave velocity. Am J Hypertens. 2006 Feb;19(2):214-9. — View Citation

Diener HC, Sacco R, Yusuf S; Steering Committee; PRoFESS Study Group. Rationale, design and baseline data of a randomized, double-blind, controlled trial comparing two antithrombotic regimens (a fixed-dose combination of extended-release dipyridamole plus — View Citation

Dzau VJ, Antman EM, Black HR, Hayes DL, Manson JE, Plutzky J, Popma JJ, Stevenson W. The cardiovascular disease continuum validated: clinical evidence of improved patient outcomes: part I: Pathophysiology and clinical trial evidence (risk factors through — View Citation

Geeganage C, Tracy M, England T, Sare G, Moulin T, Woimant F, Christensen H, De Deyn PP, Leys D, O'Neill D, Ringelstein EB, Bath PM; for TAIST Investigators. Relationship between baseline blood pressure parameters (including mean pressure, pulse pressure, — View Citation

Hong JM, Lee JS, Shin DH, Yong SW. Hemodynamic impact of fetal-variant Willisian circle on cerebral circulation: a duplex ultrasonography study. Eur Neurol. 2011;65(6):340-5. doi: 10.1159/000327213. Epub 2011 May 19. — View Citation

Jankowski P, Kawecka-Jaszcz K, Czarnecka D, Brzozowska-Kiszka M, Styczkiewicz K, Loster M, Kloch-Badelek M, Wilinski J, Curylo AM, Dudek D; Aortic Blood Pressure and Survival Study Group. Pulsatile but not steady component of blood pressure predicts cardi — View Citation

Kim DH, Choi JH, Moon JS, Kim HJ, Cha JK. Association between the severity of cerebral small vessel disease, pulsatility of cerebral arteries, and brachial ankle pulse wave velocity in patients with lacunar infarction. Eur Neurol. 2010;64(4):247-52. doi: — View Citation

Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 20 — View Citation

Lim MH, Cho YI, Jeong SK. Homocysteine and pulsatility index of cerebral arteries. Stroke. 2009 Oct;40(10):3216-20. doi: 10.1161/STROKEAHA.109.558403. Epub 2009 Jul 23. — View Citation

Lindholm LH, Ibsen H, Dahlöf B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristiansson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman J, Snapinn S; LIFE Study Group. Cardiovascular morbidi — View Citation

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 — View Citation

Neutel J, Weber M, Pool J, Smith D, Fitzsimmons S, Chiang YT, Gatlin M. Valsartan, a new angiotensin II antagonist: antihypertensive effects over 24 hours. Clin Ther. 1997 May-Jun;19(3):447-58; discussion 367-8. — View Citation

Oliveira-Filho J, Silva SC, Trabuco CC, Pedreira BB, Sousa EU, Bacellar A. Detrimental effect of blood pressure reduction in the first 24 hours of acute stroke onset. Neurology. 2003 Oct 28;61(8):1047-51. — View Citation

Roman MJ, Devereux RB, Kizer JR, Lee ET, Galloway JM, Ali T, Umans JG, Howard BV. Central pressure more strongly relates to vascular disease and outcome than does brachial pressure: the Strong Heart Study. Hypertension. 2007 Jul;50(1):197-203. Epub 2007 M — View Citation

Roman MJ, Devereux RB, Kizer JR, Okin PM, Lee ET, Wang W, Umans JG, Calhoun D, Howard BV. High central pulse pressure is independently associated with adverse cardiovascular outcome the strong heart study. J Am Coll Cardiol. 2009 Oct 27;54(18):1730-4. doi — View Citation

Safar ME, Blacher J, Pannier B, Guerin AP, Marchais SJ, Guyonvarc'h PM, London GM. Central pulse pressure and mortality in end-stage renal disease. Hypertension. 2002 Mar 1;39(3):735-8. — View Citation

Sandset EC, Bath PM, Boysen G, Jatuzis D, Kõrv J, Lüders S, Murray GD, Richter PS, Roine RO, Terént A, Thijs V, Berge E; SCAST Study Group. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlle — View Citation

Schrader J, Lüders S, Kulschewski A, Hammersen F, Plate K, Berger J, Zidek W, Dominiak P, Diener HC; MOSES Study Group. Morbidity and Mortality After Stroke, Eprosartan Compared with Nitrendipine for Secondary Prevention: principal results of a prospectiv — View Citation

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Yamashina A, Tomiyama H, Takeda K, Tsuda H, Arai T, Hirose K, Koji Y, Hori S, Yamamoto Y. Validity, reproducibility, and clinical significance of noninvasive brachial-ankle pulse wave velocity measurement. Hypertens Res. 2002 May;25(3):359-64. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Blood pressure control		12 weeks	No
Secondary	Blood pressure at the brachial artery		12 weeks	No
Secondary	Brachial-ankle pulse wave velocity (ba-PWV)	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	No
Secondary	Flow-mediated dilation (FMD)	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	No
Secondary	Pulsatile index (PI)	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	No
Secondary	Cerebral blood flow (CBF) volume	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	No
Secondary	Adverse Events		12 weeks	Yes