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Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

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ClinicalTrials.gov Identifier: NCT00329238
Recruitment Status : Completed
First Posted : May 24, 2006
Results First Posted : September 14, 2011
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (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 twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: Dabigatran Drug: Warfarin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2867 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
Study Start Date : May 2006
Actual Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dabigatran
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
 Drug: Dabigatran
Dabigatran 150 mg BID (twice daily)
Active Comparator: Warfarin (INR of 2.0-3.0)
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
 Drug: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0


Outcome Measures
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Primary Outcome Measures :
  1. Composite of Recurrent VTE or VTE Death at 36 Months [ Time Frame: 36 months ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

  2. Composite of Recurrent VTE or VTE Death at 18 Months [ Time Frame: 18 months ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.


Secondary Outcome Measures :
  1. Composite of Recurrent VTE or All Cause Death at 36 Months [ Time Frame: 36 months ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

  2. Composite of Recurrent VTE or All Cause Death at 18 Months [ Time Frame: 18 months ]
    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.

  3. Deep Vein Thrombosis (DVT) at 36 Months [ Time Frame: 36 months ]
    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

  4. DVT at 18 Months [ Time Frame: 18 months ]
    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

  5. Symptomatic Pulmonary Embolism (PE) at 36 Months [ Time Frame: 36 months ]
    Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

  6. Symptomatic Pulmonary Embolism (PE) at 18 Months [ Time Frame: 18 months ]
    Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

  7. Deaths Related to VTE at 36 Months [ Time Frame: 36 months ]
    Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

  8. Deaths Related to VTE at 18 Months [ Time Frame: 18 months ]
    Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

  9. Deaths of All Causes at 36 Months [ Time Frame: 36 months ]
    Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

  10. Deaths of All Causes at 18 Months [ Time Frame: 18 months ]
    Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

  11. Number of Participants With Bleeding Events [ Time Frame: first intake of study drug until 6 days following last intake of study drug ]

    MBE (major bleeding event) if it fulfilled at least one of the following criteria

    • Fatal bleeding
    • Symptomatic bleeding in a critical area or organ.
    • Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.

    Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs

    CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria

    • Spontaneous skin haematoma ≥25 cm2
    • Spontaneous nose bleed >5 min duration
    • Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
    • Spontaneous rectal bleeding
    • Gingival bleeding >5 min
    • Bleeding leading to hospitalisation or requiring surgical treatment
    • Bleeding leading to a transfusion of <2 units of whole blood or red cells
    • Any other bleeding event considered clinically relevant by the investigator

  12. Laboratory Analysis [ Time Frame: 18 months + 30 days follow up ]
    Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).

  13. Number of Participants With Definite Acute Coronary Syndrome (ACS) [ Time Frame: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination ]
    All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Inclusion_Criteria

  • Acute symptomatic deep vein thrombosis (DVT)
  • Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

  • Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
  • Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
  • Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329238


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00329238    
Other Study ID Numbers: 1160.47
2005-002536-94 ( EudraCT Number: EudraCT )
First Posted: May 24, 2006    Key Record Dates
Results First Posted: September 14, 2011
Last Update Posted: May 19, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Dabigatran
 Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action