Skip to content

  • About CRIS
  • Search
    • Basic Search
    • Advanced Search
    • Search by Topics
      • Condition(s)/Problem(s)
      • Intervention Type
      • Phase
    • Recently Registered
    • Recently Updated
  • FAQ
  • Statistics
  • Registration Data Set

Contact Us

criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2018/10/05
    • Registered Date : 2018/10/11
    • Last Updated Date : 2018/10/11
Background Information
1.Background  
CRIS Registration Number KCT0003254 
Unique Protocol ID GAIRB2015-61 
Public/Brief Title Comparison of the Effect on Blood Pressure Variability in acute ischemic stroke: Fimasartan vs. Valsartan 
Scientific Title Comparison of the Effect on Blood Pressure Variability in acute ischemic stroke: Fimasartan vs. Valsartan  
Acronym FIRST 
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number GAIRB2015-61 
Approval Date 2015-03-31 
Institutional Review Board  
- Name Gachon University Gil Hospital IRB  
- Address 21, Namdong-daero 774 beon-gil, Namdong-gu, Incheon 
- Telephone 032-460-2092 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Yeong-Bae Lee 
- Title Dr. 
- Telephone +82-32-460-3346 
- Affiliation Gachon University Gil Medical Center 
- Address 21, Namdong-daero 774 beon-gil, Namdong-gu, Incheon 
Contact Person for Public Queries
- Name Dong Hoon Shin 
- Title Dr. 
- Telephone +82-32-460-3346 
- Affiliation Gachon University Gil Medical Center 
- Address 21, Namdong-daero 774 beon-gil, Namdong-gu, Incheon 
Contact Person for Updating Information
- Name Dong Hoon Shin 
- Title Dr. 
- Telephone +82-32-460-3346 
- Affiliation Gachon University Gil Medical Center 
- Address 21, Namdong-daero 774 beon-gil, Namdong-gu, Incheon 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Active, not recruiting  
Date of First Enrollment 2015-07-09 , Actual
Target Number of Participant 80
Primary Completion Date 2018-02-08 , Actual
Study Completion Date 2018-03-22 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site Gachon University Gil Medical Center 
- Recruitment Status Active, not recruiting  
- Date of First Enrollment 2015-07-09 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Boryung Pharm 
- Organization Type Pharmaceutical Company  
- Project ID H1505 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Gachon University Gil Medical Center 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Background and Purpose
Hypertension is the most prevalent risk factor for stroke and is a high risk factor for population-based risk.1 Systolic blood pressure 20 mm Hg The diastolic blood pressure was estimated to increase by more than 2-fold every 10 mmHg increase in diastolic blood pressure, and to be reduced by about 40% if the systolic blood pressure was reduced by 10 mmHg or diastolic blood pressure by 5 mmHg.2 However, there is still controversy as to whether certain types of antihypertensive agents have additional benefits other than blood pressure control.2, 3
The renin-angiotensin-aldosterone system (RAAS) is a potent vasoconstrictor that enhances vascular resistance, activates the sympathetic nervous system, stores sodium and water, . Angiotensin II produced in this process acts on the receptor type 1 angiotensin receptor type 1, contracting the blood vessels, releasing aldosterone, resulting in retention of sodium and water, and activation of the sympathetic nervous system, resulting in elevated blood pressure. Angiotensin receptor antagonist (ARB) is an antagonist to the angiotensin type 1 receptor (AT-1). ARB inhibits the binding of angiotensin II to AT-1 receptors and acts to lower blood pressure.4 In other words, ARB can regulate blood pressure by three actions: decrease of vascular resistance, sympathetic nervous inactivation, and water retention inhibition. The activation of RAAS increases the concentration of angiotensin II and induces various organ damage such as heart failure, stroke and renal failure.5
In addition, angiotensin II decreases glucose uptake in muscles, creating an environment in which metabolic syndrome is prone to occur, and induces apoptosis of beta cells in the pancreas, thereby increasing the risk of developing type 2 diabetes.4 Furthermore, increased angiotensin II Aldosterone is known to cause increased sympathetic activity and vasoconstriction, and decreases nitric oxide and vascular compliance. These results suggest that increased endothelial dysfunction, atherosclerotic inflammation, and oxidation of lipid molecules may increase the risk of stroke. Therefore, ARB can reduce the effect of preventing the development of type 2 diabetes in various disease groups and species, and restoring endothelial function and inflammatory response.6
In a study published in the Heart Outcome Prevention Evaluation (HOPE) study, there was no statistically significant difference in blood pressure between the ramipril group and the control group, which is an angiotensin-converting enzyme inhibitor, and stroke, myocardial infarction and mortality decreased by 24%.7 These results suggest that continuous administration of angiotensin-receptor blocker (ARB), which is known to have fewer side effects, such as rhsartan, fffosartan, and telmisartan, Which is consistent with the results.8-10 On the other hand, studies have shown that patients with acute stroke should have better control of blood pressure in the early period because of the higher risk of clinical and neurological deterioration.11, 12 However, the administration of candesartan for seven days in the acute phase of stroke did not reduce the incidence of vascular disease death, stroke, or myocardial infarction within 6 months, and had a detrimental effect on function recovery.13 Therefore, the decision as to when to administer certain types of antihypertensive drugs in acute stroke has not been established yet.
24 hour ambulatory blood pressure monitoring is useful for the diagnosis of hypertension. Also, 24-hour active blood pressure is more related to target organ damage than clinic blood pressure and is a better predictor of cardiovascular risk. It is known that not only the blood pressure but also the standard deviation of the blood pressure, that is, the volatility of the blood pressure, can be detected. It is known that the fluctuation of the blood pressure is related to the target organ damage and the cardiovascular complication irrespectiv  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase4 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description Randomization
Arrangements of the two groups are randomly assigned 1: 1 randomly assigned by the computer at the clinical trial center. Fimasartan group (n = 40) and Valsartan group (n = 40) by random number assignment. Intervention group 1 takes 60 mg Fimasartan (Kanarb Tablet) one oral dose once a day. Intervention group 2 takes 80 mg Valsartan (Diovan Tablet) one oral dose once a day.
Research process
- This trial was conducted in a double-blind manner, in which subjects and researchers were unaware of which drugs were assigned to participate in this study. Using the drug assigned by the investigator for 2 months, (140 mmHg or less).
- Subjects will be visited twice during the post-discharge clinical trial and will be assessed based on the ABPM measured at visit.  
Number of Arms
Arm 1 Arm Label Fimasartan group 
Target Number of Participant 40 
Arm Type Experimental 
Arm Description Randomization Arrangements of the two groups are randomly assigned 1: 1 randomly assigned by the computer at the clinical trial center. Fimasartan group (n = 40) and Valsartan group (n = 40) by random number assignment. Intervention group 1 takes 60 mg Fimasartan (Kanarb Tablet) one oral dose once a day. Research process - This trial was conducted in a double-blind manner, in which subjects and researchers were unaware of which drugs were assigned to participate in this study. Using the drug assigned by the investigator for 2 months, (140 mmHg or less). - Subjects will be visited twice during the post-discharge clinical trial and will be assessed based on the ABPM measured at visit. 
Arm 2 Arm Label Valsartan group 
Target Number of Participant 40 
Arm Type Active comparator 
Arm Description 80mg Valsartan(DiovanR) Oral administration (1 tablet/day) Randomization Arrangements of the two groups are randomly assigned 1: 1 randomly assigned by the computer at the clinical trial center. Fimasartan group (n = 40) and Valsartan group (n = 40) by random number assignment. Intervention group 2 takes 80 mg Valsartan (Diovan Tablet) one oral dose once a day. Research process - This trial was conducted in a double-blind manner, in which subjects and researchers were unaware of which drugs were assigned to participate in this study. Using the drug assigned by the investigator for 2 months, (140 mmHg or less). - Subjects will be visited twice during the post-discharge clinical trial and will be assessed based on the ABPM measured at visit. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the nervous system
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 30 Year ~ No Limit
Description • Adults older than 30
• Patients with acute ischemic stroke who have symptoms described by diffusion weighted image and who are within 28 days after onset 7
• Patients whose screening systolic blood pressure is greater than 140 mmHg or who are taking antihypertensive drugs
• If the neurological deterioration stabilizes during screening and more than 48 hours have elapsed  
Exclusion Criteria • Hemorrhagic stroke patients
• Patients with somatic hypotension
• Severe stroke patients - Patients with a NIHSS (NIH Stroke Scale) score of 16 or greater
• Patients whose mean blood pressure during screening was not adjusted to more than 200 mmHg
• Patients allergic to hypertensive drugs
• Hematologic tests show abnormalities such as:
- Abnormal liver function abnormalities (SGOT, SGPT, total bilirubin, if more than twice the normal value)
- Anemia (hemoglobin <8mg / dl) or thrombocytopenia (<100,000 / mm3)
- kidney failure (serum creatinine> 2.0 mg / dl)
• Patients who are pregnant or lactating
• Patients with suspected secondary hypertension
• Patients that researchers consider inappropriate  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome difference of mean and standard deviation of the entire 24-h period and separately for the daytime period and the nighttime period between two groups after treatment, which is measured by ambulatory blood pressure monitoring. 
- Timepoint after 8 weeks 
Secondary Outcome(s) 1 
- Outcome difference of other parameters for blood pressure variability such as weighted standard deviation, coefficient of variation, average real variability. Primary and secondary outcomes were evaluated at baseline and 8 weeks 
- Timepoint after 8 weeks 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No