A phase III randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment for at least 5 days with a parenteral anticoagulant approved for this indication. - RE-COVER II

• Conditions: acute symptomatic VTE; MedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolism; MedDRA version: 9.1Level: LLTClassification code 10047251Term: Venous thrombosis deep (limbs)

• Registration Number: EUCTR2007-002631-86-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2680

Inclusion Criteria

1.Acute symptomatic uni- or bilateral DVT of the leg involving proximal veins, and/or PE confirmed by definitive objective clinical test in patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the investigator(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. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria:
Haemodynamic instability
Embolectomy is indicated or performed
Thrombolytic therapy is indicated or performed
Suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy including contraindications to heparins or
other alternate approved therapy used for initial treatment, and warfarin
5. Patients who in the investigator?s opinion should not be treated with warfarin
6. Allergy to heparins (including history of heparin induced thrombocytopenia) or other
alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one
of the excipients included in these medications
7. 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
8. Patients who in the investigator?s judgement are perceived as having an excessive risk
of bleeding, for example because of:
Hemorrhagic disorder or bleeding diathesis
Trauma or major surgery within the last month or as long as an excessive risk of
bleeding persists after these events, or planned major surgery
Any of the following intracranial pathologies: neoplasm, arteriovenous
malformation or aneurysm
History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra
articular bleeding
Gastrointestinal haemorrhage within the past 3 months
Symptomatic or endoscopically documented gastro duodenal ulcer disease in the
previous 30 days
Treatment with thrombolytic agents within 14 days before enrolment
Anticipated need of quinidine or other restricted medication during the treatment
period
Known thrombocytopenia (platelet count < 100·10**9/L)
9. Known anaemia (haemoglobin < 100 g/L)
10. Need of anticoagulant treatment for disorders other than VTE
11. 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
12. Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x
ULN based on the local lab results obtained at screening and prior to randomisation
(or central screening lab if available on time)
13. Known liver disease expected to have any potential impact on survival (e.g. acute
hepatitis, possibly active hepatitis B, hepatitis C or cirrhosis, but not Gilbert?s
syndrome or hepatitis A with complete recovery)
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. 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
i

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial;Main Objective: The primary objective is to investigate the efficacy of dabigatran etexilate 150 mg bid administered orally compared to warfarin PRN to maintain an INR of 2.0-3.0 for 6 month treatment period according to the study endpoints in patients with acute symptomatic Venous Thromboembolic Event (VTE is defined as the composite incidence of Deep Vein Thrombosis of the leg and Pulmonary Embolism).;Primary end point(s): Composite of recurrent symptomatic venous thromboembolism and<br>deaths related to VTE within 6 months (VTE is defined as the composite incidence of DVT and PE).