Thrombosis Embolism Clinical Trial
Official title:
Single-blind, Randomized Comparison of Warfarin Management Guided by NextDose Versus Management Based on Clinician Experience.
Objectives:
To understand whether the implementation of warfarin dose management using NextDose
(nextdose.org) at The First Affiliated Hospital of Soochow University (Suzhou, China)
improves the quality of anticoagulation therapy.
Endpoint Primary
1. Percentage of time within the acceptable INR range estimated using linear interpolation
during the 28 days after initiation of warfarin.
Secondary 2.1 Percentage of Time Measures 2.2 Time to Stable Dose 2.3 Safety Outcomes 2.4
Acceptability of NextDose Recommendations Exploratory 3.1 Percentage of Time Measures 3.2
Time to Stable Dose 3.3 Safety Outcomes 3.4 Acceptability of NextDose Recommendations 3.5
Model Evaluation 3.6 INR Variability
Population:
240 participants of any sex between the age of 18 and 80 years. Patients requiring treatment
with warfarin following cardiac surgery.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | December 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Scheduled to undergo cardiac surgery with planned warfarin anticoagulation for at least three months. - Age = 18 and < 80 years. - Written informed consent has been obtained. Exclusion Criteria: - Allergy to warfarin tablet or excipients. - Enrollment or planned enrollment in other research that would conflict with full participation in the study or confound the observation or interpretation of the study findings. - Patients who in the opinion of the recruiting clinician are: - unwilling or unable to comply with the protocol requirements and/or, - considered unreliable concerning the requirements for follow-up during the study and/or, compliance with drug administration. - Patient with life expectancy less than the expected duration of the trial due to concomitant disease. - Contraindication to warfarin therapy. The following are examples but not an exhaustive list: - Pregnancy. - Cerebral infarction or cerebral haemorrhage (from patients' medical record) within the 3 months prior to heart valve replacement - Severe heart failure (New York Heart Function Class IV) - Severe renal failure (CLcr (Cockcroft-Gault) =20mL / min) - Severe liver failure (Child-Pugh=10) - Abnormal liver function (elevated transaminase more than three times the upper limit of the local hospital clinical laboratory). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University | National Natural Science Foundation of China |
Boyle DA, Ludden TM, Carter BL, Becker AJ, Taylor JW. Evaluation of a Bayesian regression program for predicting warfarin response. Ther Drug Monit. 1989;11(3):276-84. — View Citation
Higashi MK, Veenstra DL, Kondo LM, Wittkowsky AK, Srinouanprachanh SL, Farin FM, Rettie AE. Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. JAMA. 2002 Apr 3;287(13):1690-8. — View Citation
Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definit — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Time Within Range | The percentage of time spent within the acceptable INR range (± 0.5 of target INR) as estimated using linear interpolation during the 28 days after initiation of warfarin. | 28 days after initiation of warfarin | |
Secondary | Percentage of Time Measure | The percentage of time spent within the acceptable INR range at day 90 after initiation of warfarin estimated by linear interpolation. | day 90 after initiation of warfarin | |
Secondary | Percentage of Time Measure | The percentage of time spent above and below the acceptable INR range at day 28, and 90 after initiation of warfarin estimated by linear interpolation. | day 28, and 90 after initiation of warfarin | |
Secondary | Time to Stable Dose | Number of days to achievement of stable dose (defined as 3 consecutive INR measurements within acceptable range for the same mean daily dose. | 90 days after initiation of warfarin | |
Secondary | Number of participants who experience at least one of the following safety events: | major bleeding within 30 days, INR of 4 or greater within 30 days, death within 30 days, and symptomatic or asymptomatic VTE confirmed by objective testing within 60 days of surgery. | 60 days of surgery. | |
Secondary | Percentage of prescribed doses within 0.625 mg of the NextDose proposed dose. | Acceptability of NextDose Recommendations | 90 days after initiation of warfarin | |
Secondary | Mean difference between the prescribed dose and the NextDose proposed dose. | Acceptability of NextDose Recommendations | 90 days after initiation of warfarin |
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