Phase 3
N=2,856
Secondary Prevention of Venous Thrombo Embolism (VTE).
Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00329238 ↗Enrolled (actual)
2,856
Serious AEs
9.3%
Results posted
Sep 2011
Primary outcome: Primary: Composite of Recurrent VTE or VTE Death at 36 Months — 26; 18; 1404; 1408 Participants — p=0.0137
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dabigatran (Drug); Warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Recurrent VTE or VTE Death at 36 Months |
26; 18; 1404; 1408 | 0.0137 sig |
| PRIMARY Composite of Recurrent VTE or VTE Death at 18 Months |
22; 17; 1408; 1409 | <0.0001 sig |
| SECONDARY Composite of Recurrent VTE or All Cause Death at 36 Months |
42; 36; 1388; 1390 | 0.4732 |
| SECONDARY Composite of Recurrent VTE or All Cause Death at 18 Months |
36; 32; 1394; 1394 | 0.8876 |
| SECONDARY Deep Vein Thrombosis (DVT) at 36 Months |
17; 13; 1413; 1413 | 0.4548 |
| SECONDARY DVT at 18 Months |
15; 12; 1415; 1414 | 0.6563 |
| SECONDARY Symptomatic Pulmonary Embolism (PE) at 36 Months |
10; 5; 1420; 1421 | 0.1925 |
| SECONDARY Symptomatic Pulmonary Embolism (PE) at 18 Months |
8; 5; 1422; 1421 | 0.3723 |
| SECONDARY Deaths Related to VTE at 36 Months |
1; 1; 1429; 1425 | 0.9921 |
| SECONDARY Deaths Related to VTE at 18 Months |
1; 1; 1429; 1425 | 0.9204 |
| SECONDARY Deaths of All Causes at 36 Months |
17; 19; 1413; 1407 | 0.7405 |
| SECONDARY Deaths of All Causes at 18 Months |
15; 16; 1415; 1410 | 0.9622 |
| SECONDARY Number of Participants With Bleeding Events |
13; 25; 80; 145; 277; 373 | 0.0577 |
| SECONDARY Laboratory Analysis |
26; 30; 23; 23; 9; 14 | — |
| SECONDARY Number of Participants With Definite Acute Coronary Syndrome (ACS) |
12; 2; 1; 5 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00329238). 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.