MedDataX Logo

Early Identification of Warfarin Maintenance Dosage

NCT ID: NCT01178034

Last Updated: 2012-10-23

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-10-31

Brief Summary

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

Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.

Detailed Description

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

The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.

Conditions

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

Atrial Fibrillation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Warfarin Dose Pharmacogenetic INR

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

pharmacogenetic warfarin dose

Warfarin maintenance dose on the basis of demographic/pharmacogenetic data

Group Type EXPERIMENTAL

Calculate warfarin dose using demographic/genetic algorithm

Intervention Type GENETIC

Age, body weight and genetic to calculate warfarin dosage

Interventions

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

Calculate warfarin dose using demographic/genetic algorithm

Age, body weight and genetic to calculate warfarin dosage

Intervention Type GENETIC

Eligibility Criteria

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

Inclusion Criteria

* Age \>18 years
* Indication to warfarin with INR between 2.0 and 3.0

Exclusion Criteria

* Pregnancy
* Drug interactions
* Basal INR \> 1.2
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 Padova

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vittorio Pengo

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vittorio Pengo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

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

Thrombosis Centre

Padua, , Italy

Site Status

Countries

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

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Pengo V, Zambon CF, Fogar P, Padoan A, Nante G, Pelloso M, Moz S, Frigo AC, Groppa F, Bozzato D, Tiso E, Gnatta E, Denas G, Padayattil Jose S, Padrini R, Basso D, Plebani M. A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naive Patients with Non-Valvular Atrial Fibrillation. PLoS One. 2015 Dec 28;10(12):e0145318. doi: 10.1371/journal.pone.0145318. eCollection 2015.

Reference Type DERIVED
PMID: 26710337 (View on PubMed)

Other Identifiers

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

1643P

Identifier Type: -

Identifier Source: org_study_id