NCT00032591

Brief Summary

Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,922

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2002

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

February 6, 2014

Completed
Last Updated

April 15, 2014

Status Verified

March 1, 2014

Enrollment Period

4.8 years

First QC Date

March 27, 2002

Results QC Date

June 12, 2013

Last Update Submit

March 18, 2014

Conditions

Atrial Fibrillation

Keywords

AFMechanical heart valve (MHV)

Outcome Measures

Primary Outcomes (1)

  • Time to First Event (Death, Stroke, Major Bleed)

    Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.

    Time to event

Secondary Outcomes (4)

  • Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)

    Full length of follow-up; average of 3 years

  • DASS at 2 Years of Follow-up

    At two years of follow-up

  • Cumulative Gain in Health Utilities at 2 Year

    After 2 years of follow-up for each subject

  • Health Care Costs at 2 Year

    After 2 years of follow-up for each subject

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing

Procedure: Weekly patient self-testing of prothrombin time

Arm 2

OTHER

High quality anticoagulation management (HQACM) with conventional monthly testing

Other: High quality anticoagulation management (HQACM) with conventional monthly testing

Interventions

Weekly patient self-testing of prothrombin timePROCEDURE
Arm 1
High quality anticoagulation management (HQACM) with conventional monthly testingOTHER

HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.

Also known as: HQACM
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be enrolled in this study, patients must:
  • have AF and/or a MHV;
  • be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
  • be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
  • be expected to survive for the duration of the study;
  • not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
  • be willing to perform PST;
  • be willing to be randomized;
  • possess adequate cognitive and language skills to follow the protocol and all related instructions;
  • be willing to participate for the full duration of the study;
  • sign the informed consent form; and
  • not be enrolled in another randomized clinical trial that involves a drug or device intervention.

You may not qualify if:

  • Patients are excluded in this study if:
  • subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
  • subject enrolled in another randomized clinical trial that involves a drug or device intervention
  • subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

VA Central California Health Care System, Fresno

Fresno, California, 93703, United States

Location

VA Medical Center, Loma Linda

Loma Linda, California, 92357, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

VA Medical Center, North Chicago

North Chicago, Illinois, 60064, United States

Location

VA Medical Center, Iowa City

Iowa City, Iowa, 52246-2208, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, 48201, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Kansas City MO

Kansas City, Missouri, 64128, United States

Location

Las Vegas

North Las Vegas, Nevada, 89036, United States

Location

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

Location

VA Western New York Healthcare System at Buffalo

Buffalo, New York, 14215, United States

Location

VA Medical Center, Syracuse

Syracuse, New York, 13210, United States

Location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Durham VA Medical Center HSR&D COE

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

VA South Texas Health Care System, San Antonio

San Antonio, Texas, 78229, United States

Location

VA Medical Center, Salem VA

Salem, Virginia, 24153, United States

Location

Wlliam S. Middleton Memorial Veterans Hospital, Madison

Madison, Wisconsin, 53705, United States

Location

VA Medical Center, San Juan

San Juan, 00921, Puerto Rico

Location

Related Publications (5)

  • Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees JE, Shih MC, Jacobson AK, Matchar DB; THINRS Site Investigators. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS). J Thromb Thrombolysis. 2010 Oct;30(3):263-75. doi: 10.1007/s11239-010-0499-8.

    PMID: 20628787RESULT

  • Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617.

    PMID: 20961244RESULT

  • Matchar DB, Jacobson AK, Edson RG, Lavori PW, Ansell JE, Ezekowitz MD, Rickles F, Fiore L, Boardman K, Phibbs C, Fihn SD, Vertrees JE, Dolor R. The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481--the Home INR Study (THINRS). J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0.

    PMID: 16082603RESULT

  • Phibbs CS, Love SR, Jacobson AK, Edson R, Su P, Uyeda L, Matchar DB; writing for the THINRS Executive Committee and Site Investigators. At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS). J Gen Intern Med. 2016 Sep;31(9):1061-7. doi: 10.1007/s11606-016-3700-8. Epub 2016 May 27.

    PMID: 27234663DERIVED

  • Matchar DB, Love SR, Jacobson AK, Edson R, Uyeda L, Phibbs CS, Dolor RJ. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481: The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis. 2015 Jul;40(1):17-25. doi: 10.1007/s11239-014-1128-8.

    PMID: 25209313DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Bob Edson
Organization
Palo Alto CSPCC
Bob.Edson@va.gov
(650) 493-5000

Study Officials

  • David B. Matchar, MD

    Durham VA Medical Center HSR&D COE

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2002

First Posted

March 28, 2002

Study Start

August 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 15, 2014

Results First Posted

February 6, 2014

Record last verified: 2014-03

Locations

US(28)PR(1)