Prevention of Thrombosis Recurrence in Patients With Low Circulating Levels of Antithrombin. - Full Text View

Sponsor:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT01382550

Purpose

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)

Condition	Intervention
Venous Thrombosis	Drug: Oral anticoagulation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prevention of Recurrent Venous Thromboembolism in Patients With Low Circulating Levels of Antithrombin. Extended Anticoagulation vs 12-Month Oral Anticoagulation

Resource links provided by NLM:

Genetics Home Reference related topics: factor V Leiden thrombophilia

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:

VTE recurrence during the 8-year follow-up [ Time Frame: At an average of 8 years of follow-up ] [ Designated as safety issue: No ]
During the 8-years follow-up, the incidence of recurrent VTE will be evaluated stratifying population according to OAT treatment and AT%. Contralateral DVT and PE will be computed as a recurrence. Ipsilateral DVT will be adjudicated recurrent if the results of the tests are worse than those obtained in previous tests or if the thrombus is diagnosed in another venous district. DVT of the arm; CT or MRI-documented occlusion of cerebral/abdominal veins; ultrasound-documented thrombosis of the great saphenous vein of the leg not involved in the first appearance will be also defined as a recurrence

Secondary Outcome Measures:

Bleeding events during the 8-year follow-up [ Time Frame: During the 8-year follow-up ] [ Designated as safety issue: Yes ]
During the 8-years follow-up, the incidence of overall (minor and major) bleedings will be evaluated stratifying population according to OAT treatment and AT%. The severity of bleeding events will be defined according to the thrombolysis in myocardial infarction (TIMI) bleeding score.

Estimated Enrollment:	900
Study Start Date:	March 1993

Groups/Cohorts	Assigned Interventions
VTE subjects subjects with a recent (<3 months) first VTE event Exclusion criteria: missing data during the follow-up; contraindications to or lack of compliance to oral anticoagulation (OAT), lack of informed consent; history of previous VTE event; indication for continuous oral anticoagulation (e.g., an artificial heart valve or chronic atrial fibrillation); events occurring during pregnancy, malignancy, puerperium, oral contraceptive intake, hormone replacement therapy; deficiencies of Prot. C and Prot S or combined inhibitor deficiencies.	Drug: Oral anticoagulation The antithrombotic treatment will be decided according to the usual practice of the enrolling Center. 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 (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 prothrombin time within the target INR range 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.

Groups/Cohorts

Assigned Interventions

VTE subjects

subjects with a recent (<3 months) first VTE event

Exclusion criteria: missing data during the follow-up; contraindications to or lack of compliance to oral anticoagulation (OAT), lack of informed consent; history of previous VTE event; indication for continuous oral anticoagulation (e.g., an artificial heart valve or chronic atrial fibrillation); events occurring during pregnancy, malignancy, puerperium, oral contraceptive intake, hormone replacement therapy; deficiencies of Prot. C and Prot S or combined inhibitor deficiencies.

Drug: Oral anticoagulation

The antithrombotic treatment will be decided according to the usual practice of the enrolling Center. 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 (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 prothrombin time within the target INR range 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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

subjects with a recent (<3 months) first VTE event enrolled for a long-term follow-up (every 6 months).

Criteria

Inclusion Criteria:

Recent (<3 months) First VTE event

Exclusion Criteria:

missing data during the follow-up; contraindications to or lack of compliance to oral anticoagulation (OAT), lack of informed consent; history of previous VTE event; indication for continuous oral anticoagulation (e.g., an artificial heart valve or chronic atrial fibrillation); events occurring during pregnancy, malignancy, puerperium, oral contraceptive intake, hormone replacement therapy; deficiencies of Prot. C and Prot S or combined inhibitor deficiencies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382550

Contacts

Contact: Giovanni Di Minno, Prof

+390817462060

diminno@unina.it

Locations

Italy
Federico II University	Recruiting
Naples, Italy, 80129
Contact: Giovanni Di Minno, Prof +390817462060 diminno@unina.it
Principal Investigator: Giovanni Di Minno, Prof

Sponsors and Collaborators

Federico II University

Investigators

Study Chair:	Giovanni Di Minno, Prof	Federico II University
Principal Investigator:	Matteo Nicola Dario Di Minno, MD	Federico II University
Principal Investigator:	Anna Maria Cerbone, MD	Federico II University
Principal Investigator:	Antonella Tufano, MD	Federico II University

More Information

No publications provided

Responsible Party:	Prof Giovanni Di Minno, Dept of Clinical and Experimental Medicine, Federico II University
ClinicalTrials.gov Identifier:	NCT01382550 History of Changes
Other Study ID Numbers:	AT 63/11
Study First Received:	June 23, 2011
Last Updated:	June 24, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by Federico II University:

antithrombin
venous thrombosis
thrombosis risk factors
thrombophilia

Additional relevant MeSH terms:

Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Antithrombins
Antithrombin III

Antithrombin Proteins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012