Effectiveness of NextDose for Warfarin Dose Individualization

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\. 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.

Conditions

• Thrombosis Embolism

Interventions

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.

Sponsors & Collaborators

• National Natural Science Foundation of China

  collaborator OTHER_GOV

• The First Affiliated Hospital of Soochow University

  lead OTHER

Principal Investigators

• Li Y Miao, PhD · The First Affiliated Hospital of Soochow University

• Zhen Y Shen, PhD · The First Affiliated Hospital of Soochow University

• Nick Holford, MBChB · University of Auckland, New Zealand

• Ling Xue, MS · The First Affiliated Hospital of Soochow University

• Guangda Ma, MHSc · University of Auckland, New Zealand

• Ying L Ding, MS · The First Affiliated Hospital of Soochow University

• Qiong Qin, MS · The First Affiliated Hospital of Soochow University

• Jacqui Hannam, PhD · University of Auckland, New Zealand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-31

Primary Completion

2021-09-30

Completion

2021-12-31