Phase 3
Completed N=2,568
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
Source: ClinicalTrials.gov NCT00680186 ↗Enrolled (actual)
2,568
Serious AEs
12.0%
Results posted
Jun 2012
Primary outcomePrimary: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE — 30; 28; 34; 30 participants — p=0.0002
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.
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 | — |
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
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. Informational only — not medical advice.