Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: matching placebo twice daily (BID); Drug: dabigatran etexilate 150 mg twice daily (BID)

• Registration Number: NCT00558259
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Primary Completion: 2011-02
• Results First Submitted: 2012-01-31
• Results First Submitted QC: 2012-01-31
• Results First Posted: 2012-03-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1353

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
matching placebo twice daily (BID)	matching placebo twice daily (BID)	Patient to receive dabigatran extexilate matching placebo capsules twice daily
dabigatran etexilate 150 mg BID	dabigatran etexilate 150 mg twice daily (BID)	Patient to receive dabigatran etexilatate capsules 150 mg twice daily

Primary Outcome Measures

Name	Time	Method
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period	6 months	Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.

Secondary Outcome Measures

Name	Time	Method
Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period	6 months	Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Centrally Confirmed Unexplained Deaths During the Intended Treatment Period	6 months	Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Laboratory Measures, Especially Liver Function Tests (LFTs)	6 months	Number of participants with possible clinically significant abnormalities during the treatment period.
Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period	6 months	Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period	6 months	Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Centrally Confirmed Bleeding Event During the Treatment Period	6 months	Major bleeding events (MBE) had to fulfil at least 1 of the following criteria: * Fatal bleeding; * Associated with a fall in haemoglobin of ≥2 g/dL; * Led to the transfusion of ≥2 units packed cells or whole blood; * Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.; Examples of these bleedings were: * Bleeding that compromised haemodynamics; * Bleeding that led to hospitalisation; Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.; All bleeding events include MBEs, CRBEs, and trivial bleeding events.
Centrally Confirmed Cardiovascular Events During the Treatment Period	6 months	Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.

Trial Locations

Locations (147)

1160.63.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1160.63.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

1160.63.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Laguna Hills, California, United States

1160.63.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Colorado Springs, Colorado, United States

1160.63.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, Florida, United States

1160.63.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 Key West, Florida, United States

1160.63.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Lafayette, Louisiana, United States

1160.63.01044 Boehringer Ingelheim Investigational Site; 🇺🇸 New Iberia, Louisiana, United States

1160.63.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Biddeford, Maine, United States

1160.63.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Salisbury, Maryland, United States

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