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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00329238
First received: May 23, 2006
Last updated: May 8, 2014
Last verified: December 2013

May 23, 2006
May 8, 2014
May 2006
October 2010   (final data collection date for primary outcome measure)
  • Composite of Recurrent VTE or VTE Death at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.
  • Composite of Recurrent VTE or VTE Death at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE during the treatment period. VTE is defined as the composite incidence of Deep Venous Thromboembolism and Pulmonary Embolism.
Complete list of historical versions of study NCT00329238 on ClinicalTrials.gov Archive Site
  • Composite of Recurrent VTE or All Cause Death at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.
  • Composite of Recurrent VTE or All Cause Death at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
  • Deep Vein Thrombosis (DVT) at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
  • DVT at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
  • Symptomatic Pulmonary Embolism (PE) at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.
  • Symptomatic Pulmonary Embolism (PE) at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
  • Deaths Related to VTE at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.
  • Deaths Related to VTE at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
  • Deaths of All Causes at 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.
  • Deaths of All Causes at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Bleeding Events [ Time Frame: first intake of study drug until 6 days following last intake of study drug ] [ Designated as safety issue: Yes ]

    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
  • Laboratory Analysis [ Time Frame: 18 months + 30 days follow up ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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.
1. Composite of recurrent symptomatic VTE and all deaths 2. Symptomatic DVT 3. Symptomatic PE 4. Deaths related to VTE 5. All deaths
Not Provided
Not Provided
 
Secondary Prevention of Venous Thrombo Embolism (VTE).
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Thromboembolism
  • Drug: Dabigatran
    Dabigatran 150 mg BID (twice daily)
  • Drug: Warfarin
    Warfarin dosed individually to maintain INR 2.0-3.0
  • Experimental: Dabigatran
    Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
    Intervention: Drug: Dabigatran
  • 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
    Intervention: Drug: Warfarin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2867
Not Provided
October 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom
 
NCT00329238
1160.47, 2005-002536-94
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP