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Venous ThrombosisNCT00162435

Genetic Determinants of Warfarin Anticoagulation Effect

A study testing Warfarin in people with Venous Thrombosis and Pulmonary Embolism, run by Hadassah Medical Organization at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteIsrael
Study dates
Aug 2002to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients in whom warfarin is about to be initiated
  • Desired therapeutic range >2 and <3

Who cannot join

  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Yoseph Caraco, MD contact

00 972 2 6778584

caraco@hadassah.org.il

Israel1 site, 1 recruiting

  • Hadassah Medical Organization

    Jerusalem

    Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il

    Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il

    Recruiting

Other trials in Israel

About this study

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

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:

  1. 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.
  2. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
  3. 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.
Being tested
Warfarin
Medical subject headings
Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00162435
Study groupRoleWhat they receive
GeneticExperimentalNot described
Receives: Drug: Warfarin
ControlExperimentalNot described
Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic end points:

    Measured: 1-4 months

  2. Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state

    Measured: 1-4 months

  3. Pharmacodynamic.

    Measured: 1-4 months

  4. Maintenance dose of warfarin at steady state.

    Measured: 1-4 months

  5. Time to reach INR > 2.

    Measured: 1-4 months

  6. Time to reach pharmacodynamic steady state.

    Measured: 1-4 months

  7. Time spent at therapeutic INR <3 and >2.

    Measured: 1-4 months

  8. Time spent at INR >3.

    Measured: 1-4 months

  9. Time spent at INR <2.

    Measured: 1-4 months

  10. The incidence of minor and major bleeding episodes.

    Measured: 1-4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2005 (estimated)
  2. Study startAug 2002
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00162435
Sponsor's protocol ID
yc19553-HMO-CTIL
Status last verified
Mar 2018
First submitted
11 Sep 2005
Last updated
12 Jun 2018
Results posted
No

Publications

  • Caraco Y, Blotnick S, Muszkat M. CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: a prospective randomized controlled study. Clin Pharmacol Ther. 2008 Mar;83(3):460-70. doi: 10.1038/sj.clpt.6100316. Epub 2007 Sep 12.

    PubMed 17851566

Questions about this trial

What is this clinical trial studying?

A study testing Warfarin in people with Venous Thrombosis and Pulmonary Embolism, run by Hadassah Medical Organization at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yoseph Caraco, MD (00 972 2 6778584, caraco@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic end points: (time frame: 1-4 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00162435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.

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