Status Approved
First Submitted Date
2014/09/18
Registered Date
2014/12/01
Last Updated Date
2016/08/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0001291 |
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Unique Protocol ID | CUH 2014-05-019 |
Public/Brief Title | The effect of warfarin on blood viscosity in patients with ischemic stroke |
Scientific Title | The effect of warfarin on blood viscosity in patients with ischemic stroke |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CUH 2014-05-019-002 |
Approval Date | 2014-08-08 |
Institutional Review Board Name | IRB of Biomedical Research Institute of Chonbuk National University Hospital |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seul-Ki Jeong |
Title | |
Telephone | +82-63-250-2387 |
Affiliation | Jeonbuk National University Hospital |
Address | 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do |
Contact Person for Public Queries | |
Name | Kim seul ki |
Title | |
Telephone | +82-63-250-1590 |
Affiliation | Jeonbuk National University Hospital |
Address | 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do |
Contact Person for Updating Information | |
Name | Seul K Kim |
Title | |
Telephone | +82-63-250-1590 |
Affiliation | Jeonbuk National University Hospital |
Address | 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2014-08-26 Actual | |
Target Number of Participant | 60 | |
Primary Completion Date | 2016-02-29 , Actual | |
Study Completion Date | 2016-02-29 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Jeonbuk National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2014-08-26 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Jeonbuk National University Hospital |
Organization Type | Medical Institute |
Project ID | CUH 2014-05-019 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Jeonbuk National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Primary Study Objective(s) 1. Determine the effect of warfarin on low-shear blood viscosity levels, as compared with intra-individual baseline levels, in atrial fibrillation patients having CHADS2 score of 2 or greater. Secondary Study Objective(s) 1. Stratify patients with atrial fibrillation having CHADS2 score of 2 or greater using complete blood viscosity profiles at baseline. 2. Investigate the variability in blood viscosity responses at shear rates of 5 and 300 s-1 as a function of baseline blood viscosity in atrial fibrillation patients having CHADS2 score of 2 or greater. Study Design Prospective, randomized, open-label, blinded-endpoint study |
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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 | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | blood viscosity effect with warfarin vs. aspirin: blood viscosity measurement in the group of warfarin Tx, with International Normalized Ratio (INR) 2-3 blood viscosity measurement in the group of aspirin Tx, with 3 days of medication |
Number of Arms | 2 |
Arm 1 |
Arm Label Warfarin Treatment group |
Target Number of Participant 30 |
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Arm Type Experimental |
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Arm Description Warfarin group; blood viscosity measurement at both the initiation of warfarin treatment and when target International Normalized Ratio (INR) reaches 2-3. Warfarin 5mg was usually tried at the beginning with INR monitoring, and final dose would be determined accoridng to INR values. |
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Arm 2 |
Arm Label Aspirin treatment group |
Target Number of Participant 30 |
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Arm Type Active comparator |
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Arm Description aspirin group; blood viscosity measurement at both the initiation of aspirin and after 5-7 days of medication Acetylsalicylic acid (Aspirin) dose was 75-100mg/day (fixed). |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (I00-I99)Diseases of the circulatory system (I64)Stroke, not specified as haemorrhage or infarction |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~90Year |
|
Description • Male or female subjects with treatment-naïve non-valvular atrial fibrillation as evidenced by documented ECG evidence. o Female subjects of childbearing potential must be abstinent or practicing methods of birth control which are recognized as effective. o Females of childbearing potential must have a negative serum β-hCG pregnancy test prior to study enrollment. • Subject has a CHADS2 stroke risk score of 2 or greater and is eligible for warfarin therapy. o Congestive heart failure, hypertension, age of 75 years or greater, and diabetes each get 1 point towards the risk score. A previous stroke, transient ischemic attack, or thromboembolism gets 2 points. • Subject is between 18 and 90 years of age. • Subject is willing to comply with the requirements of the study protocol. • Subject has given written informed consent to participate in the study. |
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Exclusion Criteria |
• Subject is pregnant or breast-feeding. • Subject has transient atrial fibrillation caused by a reversible condition (i.e. thyrotoxicosis, post-surgery) • Subject has an active infection such as endocarditis. • Subject has active internal bleeding or history of a condition associated with increased bleeding risk. • Subject has an anemia. • Subject has given blood or received a blood transfusion at any point during the study. • Subject has concurrent hyperthyroidism. • Patient has polycythemia vera or any hyperviscosity syndrome. • Platelet count <90,000/µL at initial screening. • Subject has poor diabetes or hypertension control (sustained systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg). • Subject has mitral stenosis or mechanical heart valves. • Subject is taking steroids. • Subject has a history of severe liver disease or end-stage renal disease receiving dialysis (HD or PD) or KT. • Family members or employees of the investigator or study centers involved in the study. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Blood viscosity levels of high (300/sec) and low (5/sec) shear rates |
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Timepoint | when INR reaches 5-7 or 7th day of acetylsalicylic acid treatment |
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Secondary Outcome(s) 1 | ||
Outcome | Blood viscosity distribution according to CHADS2 scores in patients with atrial fibrillation |
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Timepoint | initial screening and follow up |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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