Genotype-guided Warfarin Individualized Treatment
- Conditions
- Atrial FibrillationDeep Venous Thrombosis
- Interventions
- Behavioral: Genotype-guided dosing algorithm for warfarinBehavioral: Standard initiation dose for warfarin
- Registration Number
- NCT02211326
- Brief Summary
The purpose of this study is to determine whether the international pharmacogenetic algorithm is better than the standard initiation dosing and whether the two algorithms are suitable for Chinese elderly patients.
- Detailed Description
The study protocol is a multicenter, randomized, patient-blinded and controlled trial, comparing two approaches among 864 enrolled AF(atrial fibrillation) or DVT(deep venous thrombosis) patients for guiding warfarin initial anticoagulation in Chinese elderly patients: the intervention group using the algorithm of International Warfarin Pharmacogenetic Consortium and its dose revision, and the control group using a standard initiation dose (2.25 mg).The study hypothesis is that the intervention group relative to the control group will increase the percentage of time in therapeutic INR (international normalized ratio) range during the first 3 months.This trial is the first prospective large-scale randomized controlled trial for elders in China. It is of great significance for promoting special crowd individualization of anticoagulants at home and abroad.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description genotype-guided group Genotype-guided dosing algorithm for warfarin Interventions：on day1\~day3, patients received dose according to IWPC formula (PGx-1) included clinical variables and genotype data for VKORC1, CYP2C9\*1, CYP2C9\*2, and CYP2C9\*3; on day4\~day7, patients received dose according to Lenzini formula consisted of clinical variables, VKORC1, CYP2C9\*2, CYP2C9\*3 and previous INR and dosing information (PGx-2); and on day8, the clinicians adjusted the dose according to observed INR.The overall follow-up period is 12 weeks. control group Standard initiation dose for warfarin Interventions：on day1\~day3, patients were given initial dose (2.25mg); and starting from day4, the clinicians began to adjust the dose for patients according to observed INR.The overall follow-up period is 12 weeks.
- Primary Outcome Measures
Name Time Method %TTR 12 weeks percentage of time in the therapeutic INR (%TTR) of INR 2-3 (\<60 years old) or 1.5-2.5 (≥ 60 years old) within 12 weeks
- Secondary Outcome Measures
Name Time Method the time to reach therapeutic INR 12 weeks the time to reach therapeutic INR
the time to reach stable warfarin dose which defined as the dose to achieve INR within ±0.1 of therapeutic range at Day 8 post-dose 12 weeks the time to reach stable warfarin dose which defined as the dose to achieve INR within ±0.1 of therapeutic range at Day 8 post-dose
The number of adjustment units in the dose of warfarin (with 0.375 mg (1/8 tablet) as a unit); Incidence of INR ≥ 4 12 weeks The number of adjustment units in the dose of warfarin (with 0.375 mg (1/8 tablet) as a unit); Incidence of INR ≥ 4
Trial Locations
- Locations (15)
The Third Hospital of Changsha
🇨🇳Changsha, Hunan, China
The Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanhua university
🇨🇳Hengyang, Hunan, China
The Central Hospital of Loudi
🇨🇳Loudi, Hunan, China
The People's Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
The Central Hospital of Changsha
🇨🇳Changsha, Hunan, China
The Fourth Hospital of Changsha
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First People's Hospital of Chenzhou
🇨🇳Chenzhou, Hunan, China
The Second Affiliated Hospital of Nanhua university
🇨🇳Hengyang, Hunan, China
The Central Hospital of Xiangtan
🇨🇳Xiangtan, Hunan, China
The Central Hospital of Shaoyang
🇨🇳Shaoyang, Hunan, China
The Central Hospital of Yiyang
🇨🇳Yiyang, Hunan, China
The First People's Hospital of Shaoyang
🇨🇳Shaoyang, Hunan, China
The First People's Hospital of Xiangtan
🇨🇳Xiangtan, Hunan, China