Phase 3
N=2,539
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00291330 ↗Enrolled (actual)
2,539
Serious AEs
12.4%
Results posted
Feb 2011
Primary outcome: Primary: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE — 30; 27; 34; 32 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dabigatran etexilate 150 mg (Drug); warfarin (INR 2-3) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE |
30; 27; 34; 32 | <0.0001 sig |
| SECONDARY Number of Participants With Recurrent Symptomatic VTE and All Deaths |
48; 44; 55; 53 | 0.6220 |
| SECONDARY Number of Participants With Recurrent Symptomatic DVT |
16; 18; 17; 22 | 0.6466 |
| SECONDARY Number of Participants With Recurrent Symptomatic Non-fatal PE |
13; 7; 16; 8 | 0.2981 |
| SECONDARY Number of Participants Who Died Due to VTE |
1; 3; 1; 3 | 0.5327 |
| SECONDARY Number of Participants Who Died (Any Cause) |
21; 21; 25; 25 | 0.8018 |
| SECONDARY Number of Participants With Bleeding Events |
20; 24; 71; 111; 207; 280 | 0.5063 |
| SECONDARY Number of Participants With Acute Coronary Syndrome (ACS) |
5; 3; 4; 2; 2; 0 | — |
| SECONDARY Laboratory Analyses |
21; 22; 0; 0; 26; 38 | — |
Summary
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.
Eligibility Criteria
Inclusion criteria
- Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
- Male or female, being 18 years of age or older
- Written informed consent for study participation
Exclusion criteria
- Overt symptoms of VTE for longer than 2 weeks prior to enrolment
- PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
- Actual or anticipated use of vena cava filter
- Contraindications to anticoagulant therapy
- Patients who in the investigators opinion should not be treated with warfarin
- Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
- Known anaemia
- Need of anticoagulant treatment for disorders other than VTE
- Recent unstable cardiovascular disease
- Elevated AST or ALT > 2x ULN
- Liver disease expected to have any potential impact on survival
- Patients who have developed transaminase elevations upon exposure to ximelagatran
- Severe renal impairment
- Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
- Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
- Patients considered unsuitable for inclusion by the investigator
Data sourced from ClinicalTrials.gov (NCT00291330). 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.