Status Approved
First Submitted Date
2018/10/05
Registered Date
2018/10/11
Last Updated Date
2018/10/11
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003254 |
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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 |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | GAIRB2015-61 |
Approval Date | 2015-03-31 |
Institutional Review Board Name | Gachon University Gil Hospital IRB |
Institutional Review Board Address | 21, Namdong-daero 774 beon-gil, Namdong-gu, Incheon |
Institutional Review Board Telephone | 032-460-2092 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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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 |
4. Status
Study Site | Single | |
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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 | Gachon University Gil Medical Center | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2015-07-09 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Boryung Pharm |
Organization Type | Pharmaceutical Company |
Project ID | H1505 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Gachon University Gil Medical Center |
Organization Type | Medical Institute |
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 |
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8. Study Design
Study Type | Interventional Study |
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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 | 2 |
Arm 1 |
Arm Label Fimasartan group |
Target Number of Participant 40 |
|
Arm Type Experimental |
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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 |
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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. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I63.9)Cerebral infarction, unspecified |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 30Year~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 |
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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 |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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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. |
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Timepoint | after 8 weeks |
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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 |
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Timepoint | after 8 weeks |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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