Estudio multicéntrico en fase III, aleatorizado, doble ciego, de grupos paralelos y control activo, para evaluar la eficacia y la seguridad de dabigatran etexilato oral (150 mg bid) en comparación con warfarina (INR 2.0-3.0) para la prevención secundaria del tromboembolismo venoso. RE-MEDY. - RE-MEDY

Conditions: Confirmed Venous Thromboembolism (VTE) i.e. uni or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins and/or pulmonay embolism (PE) - treated with anticoagulant for 3 to 6 months

Registration Number: EUCTR2005-002536-94-ES

Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

1. Objectively confirmed symptomatic uni- or bilateral DVT of the leg involving proximal veins or PE, treated with approved anticoagulant therapy, or with study drug taken during participation in trial 1160.53, for 3 to 6 months at the time of screening, in patients considered at increased risk of recurrent VTE [proximal veins are: trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein]
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation

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

1. Symptomatic DVT or PE at screening
2. Patients with primary PE with suspected origin other that leg limbs (e.g. upper limbs, right heart).
3. Actual or anticipated use of vena cava filter
4. Interruption of anticoagulant therapy for 2 or more weeks during the 3-6 months of treatment for the prior VTE.
5. Patients who in the investigator’s opinion should not be treated with warfarin
6. Allergy to warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigator’s judgement are perceived as having an excessive risk of bleeding
8. Known anaemia (haemoglobin < 100 g•L-1)
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrolment (investigator’s judgement), acute bacterial endocarditis or history of myocardial infarction within the last 3 months
11. Elevated AST or ALT > 2x ULN based on the local lab results obtained at screening and prior to randomisation (or central screening lab if available on time)
12. Liver disease expected to have any potential impact on survival (e.g. acute hepatitis, or possibly active hepatitis B, hepatitis C or cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery)
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment (estimated creatinine clearance = 30 ml/min)
15. Women who are pregnant, nursing or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (NOTE: A negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study)
16. Participation in another clinical trial with an investigational drug during the last 30 days, except for the RE-COVER trial, or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator, e.g. because considered unreliable to comply with the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
18. In case of anticipated study related diagnostic procedures requiring contrast medium
(e.g. contrast venography or pulmonary angiography):
Elevated serum creatinine, which in the investigator’s opinion contraindicates these examinations
Known allergy to radio opaque contrast media or iodine, which in the investigator’s opinion contraindicates these examinations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the comparative efficacy of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to six months for confirmed acute symptomatic venous thromboembolism.;Secondary Objective: To determine the comparative safety of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment of venous thrombolembolism.;Primary end point(s): Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE during the treatment period. <br>VTE is defined as the composite incidence of DVT and PE<br>

Secondary Outcome Measures