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Genetic Determinants of Warfarin Anticoagulation Effect
This study is currently recruiting participants.
Verified March 2017 by Yosef Caraco, Hadassah Medical Organization
Sponsor:
Hadassah Medical Organization
Collaborators:
United States - Israel Binational Science Foundation
Israel Science Foundation
Ministry of Health, Israel
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162435
First received: September 11, 2005
Last updated: March 3, 2017
Last verified: March 2017
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Purpose
The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments:
- Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population.
- Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
- Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects.
| Condition | Intervention |
|---|---|
| Venous Thrombosis Pulmonary Embolism Atrial Fibrillation | Drug: Warfarin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (masked role unspecified) Primary Purpose: Treatment |
| Official Title: | Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Blood Thinners
U.S. FDA Resources
Further study details as provided by Yosef Caraco, Hadassah Medical Organization:
Primary Outcome Measures:
- Pharmacokinetic end points: [ Time Frame: 1-4 months ]
- Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state [ Time Frame: 1-4 months ]
- Pharmacodynamic. [ Time Frame: 1-4 months ]
- Maintenance dose of warfarin at steady state. [ Time Frame: 1-4 months ]
- Time to reach INR > 2. [ Time Frame: 1-4 months ]
- Time to reach pharmacodynamic steady state. [ Time Frame: 1-4 months ]
- Time spent at therapeutic INR <3 and >2. [ Time Frame: 1-4 months ]
- Time spent at INR >3. [ Time Frame: 1-4 months ]
- Time spent at INR <2. [ Time Frame: 1-4 months ]
- The incidence of minor and major bleeding episodes. [ Time Frame: 1-4 months ]
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Genetic | Drug: Warfarin |
| Experimental: Control | Drug: Warfarin |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients in whom warfarin is about to be initiated
- Desired therapeutic range >2 and <3
Exclusion Criteria:
- Refusal to participate in the study
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00162435
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162435
Contacts
| Contact: Yoseph Caraco, MD | 00 972 2 6778584 | caraco@hadassah.org.il |
Locations
| Israel | |
| Hadassah Medical Organization | Recruiting |
| Jerusalem, Israel | |
| Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
| Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |
| Principal Investigator: Yoseph Caraco, MD | |
Sponsors and Collaborators
Hadassah Medical Organization
United States - Israel Binational Science Foundation
Israel Science Foundation
Ministry of Health, Israel
Investigators
| Principal Investigator: | Yoseph Caraco, MD | Hadassah Medical Organization |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yosef Caraco, Head, Clinical Pharmacology Unit, Division of Medicine, Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00162435 History of Changes |
| Other Study ID Numbers: |
yc19553-HMO-CTIL |
| Study First Received: | September 11, 2005 |
| Last Updated: | March 3, 2017 |
Additional relevant MeSH terms:
|
Atrial Fibrillation Thrombosis Embolism Pulmonary Embolism Venous Thrombosis Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Embolism and Thrombosis Vascular Diseases Lung Diseases Respiratory Tract Diseases Warfarin Anticoagulants |
ClinicalTrials.gov processed this record on June 27, 2017