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Prevention of Thrombosis Recurrence in Patients With Low Circulating Levels of Antithrombin.

NCT01382550 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2012-09-13

No results posted yet for this study

Summary

The aim of this study is to estimate the incidence of spontaneous and provoked recurrent VTE and the bleeding events during a 10-year follow-up in subjects experiencing a first VTE stratified according to % AT levels and to treatment schedule (long-term vs 6-12 months oral anticoagulation+transient prophylaxis during high risk periods)

Conditions

  • Venous Thrombosis

Interventions

DRUG

long-lasting OAT or 12-month OAT

The antithrombotic treatment will be decided according to usual practice of enrolling Centers. The duration of the initial treatment with parenteral anticoagulation (Low Molecular Weight Heparin or Fondaparinux), the beginning of oral anticoagulation (OAT) with Vit K inhibitors and the International Normalized Ratio (PT-INR) target will be recorded. According to Center indications the OAT duration (6 months, 12 months or long-lasting) will be recorded and population will be stratified accordingly. The length of therapy will be counted from the date when a stable PT-INR is achieved. The occurrence of surgery, trauma, prolonged immobilization (\>7 days), pregnancy (VTE risk periods) during the follow-up and the use of adequate anti-thrombotic prophylaxis will be recorded.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Giovanni Di Minno, Prof · Federico II University

  • Matteo Nicola Dario Di Minno, MD · Federico II University

  • Anna Maria Cerbone, MD · Federico II University

  • Antonella Tufano, MD · Federico II University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-03-31
Primary Completion
2012-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382550 on ClinicalTrials.gov