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Trial record 26 of 591 for:    WARFARIN

Clinical and Economic Implications of Genetic Testing for Warfarin Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00964353
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE August 12, 2009
First Posted Date  ICMJE August 24, 2009
Results First Submitted Date  ICMJE October 8, 2019
Results First Posted Date  ICMJE November 25, 2019
Last Update Posted Date November 25, 2019
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Inpatient Length of Stay [ Time Frame: during hospital stay, up to 60 days ]
Inpatient length of stay
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2009)
Clinical outcomes and costs associated with the use of genetic testing will be compared to current standards of care and alternative management practices to assess the value of genotype-guided warfarin therapy algorithms for patients and payers. [ Time Frame: 30 days after discharge ]
Change History Complete list of historical versions of study NCT00964353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Supratherapeutic Dosing [ Time Frame: during hospital stay, up to 60 days ]
International Normalized Ratio
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2009)
  • Clinical outcomes: inpatient length of stay, supratherapeutic dosing, time within range, and the incidence of deep venous thrombosis (DVT), stroke, pulmonary embolus (PE), gastrointestinal bleeding (GI) and intracranial hemorrhage (ICH). [ Time Frame: one year ]
  • Direct costs of interest include: hospital costs, genetic costs, medication costs, laboratory costs, and total therapy costs in aggregate and broken down by payer. [ Time Frame: 1 month after discharge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Economic Implications of Genetic Testing for Warfarin Management
Official Title  ICMJE The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
Brief Summary The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.
Detailed Description

The overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. The project has four specific aims.

Aim 1: To contribute patients initiating therapy at the University of Chicago Medical Center (UCMC) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy.

Aim 2: To perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races.

Aim 3: To develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Aim 4: To perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Blood Coagulation Disorders
Intervention  ICMJE Drug: Warfarin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Other Name: Coumadin
Study Arms  ICMJE
  • Active Comparator: Clinically Guided Cohort
    Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
    Intervention: Drug: Warfarin
  • Experimental: Pharmacogenetically Guided Cohort
    Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
    Intervention: Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
359
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2009)
268
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • warfarin-naive patients
  • ages 18 and older
  • are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation

Exclusion Criteria:

  • patients who are not warfarin-naive
  • 17 years of age or younger
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964353
Other Study ID Numbers  ICMJE 16738B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: David O Meltzer, MD, PhD University of Chicago
PRS Account University of Chicago
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP