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.

Condition	Treatment or Intervention	Phase
Atrial Fibrillation Mechanical heart valve	Procedure: Weekly PST of prothrombin time by international normalized ratio  Procedure: Monthly HQACM	Phase IV

Further Study Details: 

Expected Total Enrollment:  3200

Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.

Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.

Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.

Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.

Study Abstract: 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 PST is that 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.

Current plans call for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

To be enrolled in this study, patients must:

• have Atrial fibrillation and/or a Mechanical heart valve;
• 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.

Alabama
      Birmingham, Birmingham,  Alabama,  35233,  United States; Not yet recruiting
California
      Loma Linda, Loma Linda,  California,  92357,  United States; Recruiting
      West LA, Los Angeles,  California,  90073,  United States; Recruiting
      Palo Alto, Palo Alto,  California,  94304,  United States; Recruiting
      Fresno, Fresno,  California,  93703,  United States; Recruiting
Colorado
      Denver, Denver,  Colorado,  80220,  United States; Recruiting
Connecticut
      West Haven, West Haven,  Connecticut,  06516,  United States; Recruiting
Illinois
      Hines, Hines,  Illinois,  60141,  United States; Recruiting
      North Chicago, North Chicago,  Illinois,  60064,  United States; Recruiting
Iowa
      Iowa City, Iowa City,  Iowa,  52246,  United States; Recruiting
Maryland
      Baltimore, Baltimore,  Maryland,  21201,  United States; Recruiting
Michigan
      Detroit, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      Minneapolis, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Missouri
      Kansas City, Kansas City,  Missouri,  64128,  United States; Recruiting
Nevada
      Reno, Reno,  Nevada,  89520,  United States; Recruiting
      Las Vegas, North Las Vegas,  Nevada,  89036,  United States; Recruiting
New York
      Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
      Syracuse, Syracuse,  New York,  13210,  United States; Recruiting
      Bronx, Bronx,  New York,  10468,  United States; Recruiting
North Carolina
      Durham, Durham,  North Carolina,  27705,  United States; Recruiting
Ohio
      Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      Oklahoma City, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Pennsylvania
      Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Rhode Island
      Providence, Providence,  Rhode Island,  02908,  United States; Recruiting
Texas
      Dallas, Dallas,  Texas,  75216,  United States; Recruiting
      San Antonio, San Antonio,  Texas,  78284,  United States; Recruiting
Virginia
      Salem, Salem,  Virginia,  24153,  United States; Recruiting
Wisconsin
      Madison, Madison,  Wisconsin,  53705,  United States; Recruiting
Puerto Rico
      San Juan, San Juan,  00921,  Puerto Rico; Recruiting

Study ID Numbers:  481
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  March 27, 2002
ClinicalTrials.gov Identifier:  NCT00032591
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08