Status:
COMPLETED
Genotype-guided Warfarin Individualized Treatment
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Conditions:
Atrial Fibrillation
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 elde...
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 g...
Eligibility Criteria
Inclusion
- Inclusion criteria：1) Chinese male or female aged ≥18 years; 2) Requiring at least 12-week warfarin therapy as judged by clinicians; 3) Subjects with DVT/AF and a post-therapy target INR of 1.5-2.5; 4) Capable of providing written informed consent; 5) Capable of maintaining excellent communications with investigators and completing trial in accordance with trial stipulations.
- Exclusion criteria：1) Subjects previously taking warfarin; 2) Known genotypes of CYP2C9 or/and VKORC1; 3) Subjects receiving or expecting to receive other therapies or other anticoagulants; 4) Subjects with contraindications for warfarin; 5) Subjects with severe cognitive dysfunctions; 6) Baseline INR ≥1.5; 7) Subjects with drug or alcohol dependence within the last 12 months; 8) Subjects receiving blood transfusion or bone marrow transplantation within the last 2 weeks; 9) Planning to receive invasive examinations (except for standard endoscopy) with a hemorrhagic tendency or undergoing surgery during trial.10) Prior to randomization, subjects receiving any trial drug or device within the last 3 months or planning to receive such an investigational therapy during trial; 11) Subjects with the following diagnoses or conditions: active malignant carcinomas (diagnosed within the last 5 years), but excluding adequately-treated non-melanoma skin cancer or other non-invasive or in situ cancer (e.g. cervical cancer in situ); anti-neoplastic therapy within the last 5 years (medication, radiotherapy or/and surgery); overt active disease or infection; life expectancy \<6 months; 12）Other clinical reasons for unsuitable recruitment as judged by clinicians.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT02211326
Start Date
September 1 2014
End Date
May 1 2017
Last Update
November 6 2017
Active Locations (15)
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1
The People's Hospital of Hunan Province
Changsha, Hunan, China, 410002
2
The Central Hospital of Changsha
Changsha, Hunan, China, 410004
3
The Fourth Hospital of Changsha
Changsha, Hunan, China, 410006
4
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013