Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005684 |
| Other study ID # |
4108 |
| Secondary ID |
P50HL054502 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
May 25, 2000 |
| Last updated |
May 12, 2016 |
| Start date |
March 1996 |
| Est. completion date |
January 2001 |
Study information
| Verified date |
February 2005 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
