Phase 3 N=2,568 Randomized Double-blind Treatment

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT00680186 ↗

Enrolled (actual)

2,568

Serious AEs

12.0%

Results posted

Jun 2012

Primary outcome: Primary: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE — 30; 28; 34; 30 participants — p=0.0002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Warfarin (Drug); Dabigatran etexilate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE	30; 28; 34; 30	0.0002 sig
SECONDARY Number of Participants With Recurrent Symptomatic VTE and All Deaths	51; 48; 57; 51	0.6932
SECONDARY Number of Participants With Recurrent Symptomatic DVT	25; 17; 28; 17	0.1703
SECONDARY Number of Participants With Recurrent Symptomatic Non-fatal PE	7; 13; 9; 15	0.2283
SECONDARY Number of Participants Who Died Due to VTE	3; 0; 3; 0	0.0830
SECONDARY Number of Participants Who Died (Any Cause)	25; 25; 29; 26	0.7348
SECONDARY Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE	8; 13; 10; 15	0.3210
SECONDARY Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events	15; 22; 64; 102; 200; 285	<0.0001 sig
SECONDARY Number of Participants With Acute Coronary Syndrome (ACS)	3; 0; 2; 1	—
SECONDARY Laboratory Analyses	29; 27; 0; 0; 31; 40	—

Summary

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Eligibility Criteria

Inclusion criteria

Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
Male or female, being 18 years of age or older
Written informed consent for study participation

Exclusion criteria

Persistent symptoms of VTE
PE requiring urgent intervention
Use of vena cava filter
Contraindications to anticoagulant therapy
Allergy to study medications
Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
Severe renal impairment
Patients considered unsuitable for inclusion

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Data sourced from ClinicalTrials.gov (NCT00680186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.