Thrombosis EmbolismPhase 4NCT04510805
Effectiveness of NextDose for Warfarin Dose Individualization
A Phase 4 study testing NextDose (nextdose.org) in people with Thrombosis Embolism, run by The First Affiliated Hospital of Soochow University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombosis Embolism
- What is being tested?
- NextDose (nextdose.org)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
Endpoint Primary
- 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.
Read the detailed description
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
- 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
- Percentage of time within the acceptable INR Range estimated using linear interpolation during the 90 days after initiation of warfarin.
- Percentage of time spent above and below the acceptable INR range at day 28, and 90 after initiation of warfarin estimated by linear interpolation. 2.2 Time to Stable Dose a. Number of days to achievement of stable dose (defined as 3 consecutive INR measurements within acceptable range for the same mean daily dose). 2.3 Safety Outcomes a. 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. 2.4 Acceptability of NextDose Recommendations
- Percentage of prescribed doses within 0.625 mg of the NextDose proposed dose.
- Mean difference between the prescribed dose and the NextDose proposed dose. Exploratory 3.1 Percentage of Time Measures
- The percentage of time spent within, above and below the acceptable INR range estimated by numerical integration with the Bayesian parameter estimates of the PKPD model at day 28 and at day 90 after initiation of warfarin. 3.2 Time to Stable Dose a) Days to first INR measurement within the acceptable range. b) Days to second consecutive INR measurement within the acceptable range. c) Number of dose adjustments to achievement of stable dose (3 consecutive INR measurements within acceptable range for the same mean daily dose).
- Total number of dose adjustments at day 90. e) Total number of INR measurements at day 90. 3.3 Safety Outcomes
- Incidence of minor and major bleeding events. b) Incidence of thromboembolic events. c) 30 day all-cause mortality. d) 90 day all-cause mortality. e) 90 day cardiovascular mortality. f) Number of warfarin doses withheld due to high INR (as determined by the treating clinician). 3.4 Acceptability of NextDose Recommendations a) Percentage of prescribed doses within 20% of the NextDose proposed dose. 3.5 Model Evaluation
- Predictive performance of the model for patients with steady-state warfarin doses below 2 or above 7 mg/day. 3.6 INR Variability
- INR variability as described by Lind et al. (the standard deviation of transformed INR values). Population:
240 participants of any sex between the age of 18 and 80 years. Patients requiring treatment with warfarin following cardiac surgery.
- Conditions
- Thrombosis Embolism
- Being tested
- NextDose (nextdose.org)
- Keywords
- warfarin; PKPD; Bayesian forecasting
- Medical subject headings
- Embolism and Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NextDose (nextdose.org)Device
NextDose guided warfarin management taking into consideration covariates (sex, age, weight, height CYP2C9 (rs1057910) and VKORC1 (rs9923231), the dosing and INR history of each patient to predict an individualized dose in accordance with the theory-based warfarin model and target concentration intervention principles.
Initial recommended warfarin dose, up to the first INR, will be the maintenance dose predicted from group values, subsequently the NextDose predicted maintenance dose will be recommended. The treating clinician will also be provided with the NextDose report to inform the choice of the prescribed dose.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | NextDose guided warfarin management taking into consideration covariates (sex, age, weight, height CYP2C9 (rs1057910) and VKORC1 (rs9923231), the dosing and INR history of each patient to predict an individualized dose in accordance with the theory-based warfarin model and target concentration intervention principles.
Initial recommended warfarin dose, up to the first INR, will be the maintenance dose predicted from group values, subsequently the NextDose predicted maintenance dose will be recommended. The treating clinician will also be provided with the NextDose report to inform the choice of the prescribed dose. Receives: Device: NextDose (nextdose.org) |
| Control Arm | No intervention | Usual standard of care. Clinical experience of the treating physician taking into account the covariates, dosing and INR history of each patient, to determine the initial, and subsequent maintenance doses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after initiation of warfarin
Secondary outcomes (6)
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.
Measured: day 90 after initiation of warfarin
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.
Measured: day 28, and 90 after initiation of warfarin
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.
Measured: 90 days after initiation of warfarin
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.
Measured: 60 days of surgery.
Percentage of prescribed doses within 0.625 mg of the NextDose proposed dose.
Acceptability of NextDose Recommendations
Measured: 90 days after initiation of warfarin
Mean difference between the prescribed dose and the NextDose proposed dose.
Acceptability of NextDose Recommendations
Measured: 90 days after initiation of warfarin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thrombosis EmbolismStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Current warfarin dose individualization methods tend to be empirical, rather than based upon pharmacological and statistical principles. A theory-based model of warfarin pharmacokinetics and pharmacodynamics (PKPD) has been developed for dose individualization when used in conjunction with a Bayesian forecasting tool (NextDose). This study compares standard of care clinician judgement for warfarin management with the use of a web-based dosing tool (NextDose). Computer-assisted anticoagulant dosing has been shown to be helpful using empirical models. This study will evaluate a theory-based model which has shown superior performance over empirical models in predicting clinical doses of warfarin. The study is also guided by quality and service improvement principles.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Miao Liyan, The First Affiliated Hospital of Soochow University
- Investigators
- Li Y Miao, PhD, Principal investigator, The First Affiliated Hospital of Soochow UniversityZhen Y Shen, PhD, Principal investigator, The First Affiliated Hospital of Soochow UniversityNick Holford, MBChB, Study director, University of Auckland, New ZealandLing Xue, MS, Study director, The First Affiliated Hospital of Soochow UniversityGuangda Ma, MHSc, Study director, University of Auckland, New ZealandYing L Ding, MS, Study director, The First Affiliated Hospital of Soochow UniversityQiong Qin, MS, Study director, The First Affiliated Hospital of Soochow UniversityJacqui Hannam, PhD, Study director, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510805
- Sponsor's protocol ID
- 2020025
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheiner LB. Computer-aided long-term anticoagulation therapy. Comput Biomed Res. 1969 Dec;2(6):507-18. doi: 10.1016/0010-4809(69)90030-5. No abstract available.
PubMed 5367362Boyle 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. doi: 10.1097/00007691-198905000-00010.
PubMed 2728086Xue L, Holford N, Ding XL, Shen ZY, Huang CR, Zhang H, Zhang JJ, Guo ZN, Xie C, Zhou L, Chen ZY, Liu LS, Miao LY. Theory-based pharmacokinetics and pharmacodynamics of S- and R-warfarin and effects on international normalized ratio: influence of body size, composition and genotype in cardiac surgery patients. Br J Clin Pharmacol. 2017 Apr;83(4):823-835. doi: 10.1111/bcp.13157. Epub 2016 Nov 25.
PubMed 27763679Higashi 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. doi: 10.1001/jama.287.13.1690.
PubMed 11926893Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
PubMed 15842354Leon 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 definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7.
PubMed 21216553Xue L, Ma G, Holford N, Qin Q, Ding Y, Hannam JA, Ding X, Fan H, Ji Z, Yang B, Shen H, Shen Z, Miao L. A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization. Clin Pharmacol Ther. 2024 Jun;115(6):1316-1325. doi: 10.1002/cpt.3207. Epub 2024 Mar 4.
PubMed 38439157
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Randomized Comparison of Warfarin Management Guided by NextDose Versus Management Based on Clinician Experience.
- ClinicalTrials.gov ID
- NCT04510805
- Acronym / sponsor ID
- 2020025
- Conditions
- Thrombosis Embolism
- Keywords
- warfarin; PKPD; Bayesian forecasting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Aug 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Detailed description
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
- 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
- Percentage of time within the acceptable INR Range estimated using linear interpolation during the 90 days after initiation of warfarin.
- Percentage of time spent above and below the acceptable INR range at day 28, and 90 after initiation of warfarin estimated by linear interpolation. 2.2 Time to Stable Dose a. Number of days to achievement of stable dose (defined as 3 consecutive INR measurements within acceptable range for the same mean daily dose). 2.3 Safety Outcomes a. 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. 2.4 Acceptability of NextDose Recommendations
- Percentage of prescribed doses within 0.625 mg of the NextDose proposed dose.
- Mean difference between the prescribed dose and the NextDose proposed dose. Exploratory 3.1 Percentage of Time Measures
- The percentage of time spent within, above and below the acceptable INR range estimated by numerical integration with the Bayesian parameter estimates of the PKPD model at day 28 and at day 90 after initiation of warfarin. 3.2 Time to Stable Dose a) Days to first INR measurement within the acceptable range. b) Days to second consecutive INR measurement within the acceptable range. c) Number of dose adjustments to achievement of stable dose (3 consecutive INR measurements within acceptable range for the same mean daily dose).
- Total number of dose adjustments at day 90. e) Total number of INR measurements at day 90. 3.3 Safety Outcomes
- Incidence of minor and major bleeding events. b) Incidence of thromboembolic events. c) 30 day all-cause mortality. d) 90 day all-cause mortality. e) 90 day cardiovascular mortality. f) Number of warfarin doses withheld due to high INR (as determined by the treating clinician). 3.4 Acceptability of NextDose Recommendations a) Percentage of prescribed doses within 20% of the NextDose proposed dose. 3.5 Model Evaluation
- Predictive performance of the model for patients with steady-state warfarin doses below 2 or above 7 mg/day. 3.6 INR Variability
- INR variability as described by Lind et al. (the standard deviation of transformed INR values). Population:
240 participants of any sex between the age of 18 and 80 years. Patients requiring treatment with warfarin following cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Current warfarin dose individualization methods tend to be empirical, rather than based upon pharmacological and statistical principles. A theory-based model of warfarin pharmacokinetics and pharmacodynamics (PKPD) has been developed for dose individualization when used in conjunction with a Bayesian forecasting tool (NextDose). This study compares standard of care clinician judgement for warfarin management with the use of a web-based dosing tool (NextDose). Computer-assisted anticoagulant dosing has been shown to be helpful using empirical models. This study will evaluate a theory-based model which has shown superior performance over empirical models in predicting clinical doses of warfarin. The study is also guided by quality and service improvement principles.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: NextDose (nextdose.org)NextDose guided warfarin management taking into consideration covariates (sex, age, weight, height CYP2C9 (rs1057910) and VKORC1 (rs9923231), the dosing and INR history of each patient to predict an individualized dose in accordance with the theory-based warfarin model and target concentration intervention principles. Initial recommended warfarin dose, up to the first INR, will be the maintenance dose predicted from group values, subsequently the NextDose predicted maintenance dose will be recommended. The treating clinician will also be provided with the NextDose report to inform the choice of the prescribed dose. |
| Control Arm | No intervention | –Usual standard of care. Clinical experience of the treating physician taking into account the covariates, dosing and INR history of each patient, to determine the initial, and subsequent maintenance doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NextDose (nextdose.org)NextDose guided warfarin management taking into consideration covariates (sex, age, weight, height CYP2C9 (rs1057910) and VKORC1 (rs9923231), the dosing and INR history of each patient to predict an individualized dose in accordance with the theory-based warfarin model and target concentration intervention principles. Initial recommended warfarin dose, up to the first INR, will be the maintenance dose predicted from group values, subsequently the NextDose predicted maintenance dose will be recommended. The treating clinician will also be provided with the NextDose report to inform the choice of the prescribed dose. | Device | Intervention Arm |
Primary outcome
Percentage of Time Within Range
Time frame: 28 days after initiation of warfarin
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.
6 secondary outcomes
Percentage of Time Measure
Time frame: day 90 after initiation of warfarin
Percentage of Time Measure
Time frame: day 28, and 90 after initiation of warfarin
Time to Stable Dose
Time frame: 90 days after initiation of warfarin
Number of participants who experience at least one of the following safety events:
Time frame: 60 days of surgery.
Percentage of prescribed doses within 0.625 mg of the NextDose proposed dose.
Time frame: 90 days after initiation of warfarin
Mean difference between the prescribed dose and the NextDose proposed dose.
Time frame: 90 days after initiation of warfarin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Results publication: PubMed 5367362Sheiner LB. Computer-aided long-term anticoagulation therapy. Comput Biomed Res. 1969 Dec;2(6):507-18. doi: 10.1016/0010-4809(69)90030-5. No abstract available.
- Results publication: PubMed 2728086Boyle 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. doi: 10.1097/00007691-198905000-00010.
- Results publication: PubMed 27763679Xue L, Holford N, Ding XL, Shen ZY, Huang CR, Zhang H, Zhang JJ, Guo ZN, Xie C, Zhou L, Chen ZY, Liu LS, Miao LY. Theory-based pharmacokinetics and pharmacodynamics of S- and R-warfarin and effects on international normalized ratio: influence of body size, composition and genotype in cardiac surgery patients. Br J Clin Pharmacol. 2017 Apr;83(4):823-835. doi: 10.1111/bcp.13157. Epub 2016 Nov 25.
- Results publication: PubMed 11926893Higashi 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. doi: 10.1001/jama.287.13.1690.
- Results publication: PubMed 15842354Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
- Results publication: PubMed 21216553Leon 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 definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7.
- Derived from this study: PubMed 38439157Xue L, Ma G, Holford N, Qin Q, Ding Y, Hannam JA, Ding X, Fan H, Ji Z, Yang B, Shen H, Shen Z, Miao L. A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization. Clin Pharmacol Ther. 2024 Jun;115(6):1316-1325. doi: 10.1002/cpt.3207. Epub 2024 Mar 4.
- NextDoseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Y Miao, PhD principal investigator
The First Affiliated Hospital of Soochow University
Zhen Y Shen, PhD principal investigator
The First Affiliated Hospital of Soochow University
Nick Holford, MBChB study director
University of Auckland, New Zealand
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NextDose (nextdose.org) in people with Thrombosis Embolism, run by The First Affiliated Hospital of Soochow University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Xue, MS (+8651267972699 ext. +8651267972699, xueling726@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time Within Range (time frame: 28 days after initiation of warfarin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510805, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.