We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Anticoagulant Therapy for Venous Thrombosis - SCOR in Thrombosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005684
First Posted: May 26, 2000
Last Update Posted: May 13, 2016
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.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To perform a randomized clinical trial comparing continuing one month of treatment with heparin in patients with deep venous thrombosis to standard care using heparin for five days and oral warfarin for three months.

Condition Intervention Phase
Venous Thrombosis Cardiovascular Diseases Venous Thromboembolism Drug: warfarin Drug: heparin Phase 3

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: March 1996
Study Completion Date: January 2001
Detailed Description:

BACKGROUND:

The study, a subproject within a SCOR in Thrombosis, should help to improve the long-term clinical outcome of patients with proximal deep-vein thrombosis (popliteal, femoral or iliac vein thrombosis) by improving their survival and reducing morbidity from recurrent thromboembolic events, and should help to determine if one or more specific biochemical measures, including antiphospholipid antibodies and activated factor VII, will define a subset of patients at increased risk of recurrent venous thromboembolism.

The study is part of a SCOR in Hemostatic and Thrombotic Diseases, the RFA for which was released by the NHLBI in April 1994.

DESIGN NARRATIVE:

Warfarin Trial

A multicenter, randomized clinical trial was conducted from March 1996 through January 2001 comparing warfarin therapy for three years to warfarin therapy for three months. The study was performed at thirteen participating hospitals in Oklahoma. The 600 hundred patients were recruited, randomized to either warfarin therapy for three years or warfarin therapy for three months and followed for at least three years. The primary outcome measure was total mortality. Secondary outcome measures included vascular death, objectively documented recurrent venous thromboembolism, and bleeding complications (major and minor). Additional specific aims included: determining the prevalence of antiphospholipid antibodies, antithrombomodulin antibodies, and activated protein C resistance in consecutive patients with proximal-vein thrombosis; determining if these measures, and/or the level of activated factor VII were associated with an increased risk of recurrent venous thromboembolic events, and if so, whether these events were reduced by continuing long term warfarin treatment. These latter specific aims were achieved by performing the laboratory parameters concurrently in patients entered into the clinical trial, and relating these measures to the clinical outcomes on long-term follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005684


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Gary Raskob Oklahoma Medical Research Foundation
  More Information

ClinicalTrials.gov Identifier: NCT00005684     History of Changes
Other Study ID Numbers: 4108
P50HL054502 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: May 13, 2016
Last Verified: February 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Heparin
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action