Safer Warfarin Treatment

NCT ID: NCT01042067

Last Updated: 2011-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Venous Thrombosis Pulmonary Embolism Heart Valve Prosthesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Warfarin treatment group

Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment.

Blood specimens (whole blood, serum, plasma)

Intervention Type OTHER

The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood specimens (whole blood, serum, plasma)

The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Caucasian
* \>18 years of age
* included in the study at the onset of warfarin treatment
* target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)
* standard indications for warfarin treatment

Exclusion Criteria

* Non-caucasian
* Clinical significant liver affection
* Heart failure, NYHA class III-IV
* Non-compliant - not able to accomplish protocol demands
* Not able to give informed consent
* Long-term antibiotic therapy
* Malabsorption conditions and inflammatory bowel disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role collaborator

Norwegian Medicines Agency

OTHER_GOV

Sponsor Role collaborator

Norway: South-Eastern Norway Regional Health Authority

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oslo University Hospital

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-001895-18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pharmacogenetic Dosing of Warfarin
NCT02065388 COMPLETED PHASE3