Genetic Determinants of Warfarin Anticoagulation Effect
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
Collaborators:
Israel Binational Science Foundation, United States
Israel Science Foundation
Ministry of Health, Israel
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162435
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 2008
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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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind 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 Hadassah Medical Organization:
Primary Outcome Measures:
- Pharmacokinetic end points:
- Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
- Pharmacodynamic.
- Maintenance dose of warfarin at steady state.
- Time to reach INR > 2.
- Time to reach pharmacodynamic steady state.
- Time spent at therapeutic INR <3 and >2.
- Time spent at INR >3.
- Time spent at INR <2.
- The incidence of minor and major bleeding episodes.
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2002 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Israel Binational Science Foundation, United States
Israel Science Foundation
Ministry of Health, Israel
Investigators
| Principal Investigator: | Yoseph Caraco, MD | Hadassah Medical Organization |
More Information
No publications provided by Hadassah Medical Organization
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00162435 History of Changes |
| Other Study ID Numbers: | yc19553-HMO-CTIL |
| Study First Received: | September 11, 2005 |
| Last Updated: | October 28, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Atrial Fibrillation Pulmonary Embolism Venous Thrombosis Arrhythmias, Cardiac Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Lung Diseases |
Pathologic Processes Respiratory Tract Diseases Thrombosis Vascular Diseases Warfarin Anticoagulants Hematologic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015