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Trial record 23 of 226 for:    warfarin AND International

Genotype-guided Warfarin Individualized Treatment

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ClinicalTrials.gov Identifier: NCT02211326
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Deep Venous Thrombosis Behavioral: Genotype-guided dosing algorithm for warfarin Behavioral: Standard initiation dose for warfarin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pharmacogenetic Algorithm of Response to Warfarin During Initial Anticoagulation in Chinese Elderly Patients
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : January 16, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: genotype-guided group
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.
Behavioral: Genotype-guided dosing algorithm for warfarin
Intervention:initial dosing of warfarin for the first 3 days of treatment will be determined by IWPC( International Warfarin Pharmacogenetics Consortium) algorithm (PG-1),a second dose adjustment will be made after 3 doses of warfarin using a dose revision algorithm (PG-2) that combined INR values,the dose will be adjusted depending on the measurements of INR values after 7 days.The overall follow-up period is 12 weeks.

Active Comparator: control group
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.
Behavioral: Standard initiation dose for warfarin
Intervention:initial dosing of warfarin for the first 3 days of treatment will be determined by standard initiation dose. Following this initiation dose of warfarin,the dose will be adjusted depending on the measurements of INR values after 3 days.The overall follow-up period is 12 weeks.




Primary Outcome Measures :
  1. %TTR [ Time Frame: 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 :
  1. the time to reach therapeutic INR [ Time Frame: 12 weeks ]
    the time to reach therapeutic INR

  2. 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 [ Time Frame: 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

  3. The number of adjustment units in the dose of warfarin (with 0.375 mg (1/8 tablet) as a unit); Incidence of INR ≥ 4 [ Time Frame: 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


Other Outcome Measures:
  1. the number of additional clinic visits [ Time Frame: 12 weeks ]
    the number of additional clinic visits



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211326


Locations
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China, Hunan
The People's Hospital of Hunan Province
Changsha, Hunan, China, 410002
The Central Hospital of Changsha
Changsha, Hunan, China, 410004
The Fourth Hospital of Changsha
Changsha, Hunan, China, 410006
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
The Third Hospital of Changsha
Changsha, Hunan, China
The Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China, 423000
The First Affiliated Hospital of Nanhua university
Hengyang, Hunan, China
The Second Affiliated Hospital of Nanhua university
Hengyang, Hunan, China
The Central Hospital of Loudi
Loudi, Hunan, China, 417000
The Central Hospital of Shaoyang
Shaoyang, Hunan, China, 422000
The First People's Hospital of Shaoyang
Shaoyang, Hunan, China, 422001
The Central Hospital of Xiangtan
Xiangtan, Hunan, China, 411100
The First People's Hospital of Xiangtan
Xiangtan, Hunan, China, 411101
The Central Hospital of Yiyang
Yiyang, Hunan, China, 413000
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
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Principal Investigator: GuoPing Yang, professor The Third Xiangya Hospital of Central South University

Publications:

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Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02211326     History of Changes
Other Study ID Numbers: XY3-WARF1405A01
ChiCTR-TRC-14004757 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by The Third Xiangya Hospital of Central South University:
AF or DVT
Age Over 18 Years, Acquired
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Thrombosis
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Anticoagulants