Phase 2
Completed N=1,949
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Source: ClinicalTrials.gov NCT01225822 ↗Enrolled (actual)
1,949
Serious AEs
7.1%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants With Venous Thromboembolic (VTE) Events — 86; 49; 39; 47 participants — p=<0.0001
Summary
The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Venous Thromboembolic (VTE) Events |
86; 49; 39; 47; 72 | <0.0001 sig |
| PRIMARY Number of Participants With Major Bleeding Events (MBE) |
1; 16; 15; 18; 8 | 0.0077 sig |
| SECONDARY Number of Participants With VTE Events and All Cause Mortality |
86; 49; 39; 47; 72 | <0.0001 sig |
| SECONDARY Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality |
15; 11; 5; 6; 17 | 0.0373 sig |
| SECONDARY Number of Participants With Proximal DVT |
15; 9; 5; 6; 17 | 0.036 sig |
| SECONDARY Volume of Blood Loss |
523.3; 1538.4; 631.4; 910.3; 945.5 | — |
| SECONDARY Rate of Transfusions Due to Bleedings |
0.26; 5.38; 4.07; 4.94; 3.57 | 0.0063 sig |
| SECONDARY Number of Participants With Clinically Significant, Minor or Any Bleeding Events |
9; 16; 20; 19; 10; 18 | — |
| SECONDARY Laboratory Analyses |
16; 15; 14; 14; 22; 122 | — |
| SECONDARY Plasma Concentration (Cmax) of Dabigatran |
24.5; 60.5; 79.9; 132; 48.0; 165 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve During a Dosing Interval |
229; 636; 605; 1610; 350; 1250 | — |
Eligibility Criteria
Inclusion criteria
- Patients scheduled to undergo a primary elective total hip or knee replacement.
- Male of female being 18 years or older.
- Patients weighing at least 40 kg.
- Written informed consent for study participation.
Exclusion criteria
- Bleeding diathesis, constitutional or acquired coagulation disorders.
- Major surgery or trauma(e.g., hip fracture) within the last 3 months.
- Cardiovascular disease
- Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.
- Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.
- History of or acute intracranial disease
- Liver disease
- Renal disease
- Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.
- Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control
- Known allergy to contrast media
- Thrombocytopenia
- Allergy against heparin.
- Active malignant disease or current cytostatic treatment.
- Treatment with an investigational drug in the past month.
- Leg amputee
- Known alcohol or drug abuse
Data sourced from ClinicalTrials.gov (NCT01225822). 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.