ong term subcutaneous tinzaparin compared with tinzaparin and oral anticoagulants in the treatment of acute pulmonary embolism. A multicentre, prospective, randomised, open, parallel group clinical trial.

• Conditions: Patients with clinical suspicion of Pulmonar Thromboembolism confirmed according to the PIOPED criteria.; MedDRA version: 4.0Level: PTClassification code 10037377

• Registration Number: EUCTR2004-002019-97-ES
• Lead Sponsor: FARMACUSI, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Patients with clinical suspicion of Pulmonar Thromboembolism, which future confirmed diagnostic with perfusion lung scan (high probability according to PIOPED criteria), spiral computed tomography, or pulmonary angiography.

Patients should have 18 years or more, give consent and accept to be treated with an injected product at home, being capable to self administrated or with a closer person.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with massive Pulmonar Thromboembolism , with haemodinamic instability, where the fibrinolitic treatment would be indicated.
Indication of permanent anticoagulant treatment (eg. mechanical valve, auricular fibrilation, known genetical defect that would suppose an hipercoagulation state).
Pregnancy women.
Life expectancy less than 6 months.
Risk of bleeding, contraindication of acenocumarol, tinzaparin or other heparins.
platelet count <100000/mm3.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determinate the efficacy and feasibility of the ambulatory treatment with tinzaparin in the secondary profilaxis of pulmonar thromboembolism compared with acenocumarole.;Secondary Objective: Compare the safety of these 2 drugs<br>Compare the hospital stay with both treatments<br>Compare the direct and indirect costs in every group;Primary end point(s): The efficacy of both treatments will be evaluated with the number of thromboembolic recurrences for each drug.