Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis. The Einstein-DVT dose-finding study.

Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis to assess the dose-effect relationship and determine the optimum dose.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000597695

Enrollment

543

Registered

2005-10-05

Start date

2004-12-24

Completion date

2005-08-11

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

To assess the dose-effect relationship of once-daily BAY 59-7939 in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) using the combination of (LMW) heparin and vitamin K antagonist (VKA) as comparator. To determine the optimum once daily dose of BAY 59-7939 for use in phase III studies. Patients will receive either BAY 59-7939 (20, 30 or 40 mg, once-daily) or the combination of (LMW) heparin/VKA (INR 2.0-3.0). The study duration is 12 weeks followed by an additional

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Confirmed acute symptomatic DVT, i.e., proximal or extensive calf-vein thrombosis, involving at least the upper third part of the calf veins without concomitant symptomatic PE 2. Written informed consent.

Exclusion criteria

1. Under 18 years of age.2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT3. Other indication for VKA than DVT4. More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization5. Participation in another pharmacotherapeutic study within 30 days6. Creatinine clearance < 30 ml/min, impaired liver function (transaminases > 2 x ULN), or bacterial endocarditis7. Life expectancy <3 months8. Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin 9. Uncontrolled hypertension: systolic blood pressure >200 mmHg and diastolic blood pressure >110 mmHg10. Pregnancy or childbearing potential without proper contraceptive measures11. Any other contraindication listed in the local labeling of warfarin, acenocoumarol, phenprocoumon, fluidione, UFH, enoxaparin, or tinzaparin 12. Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazol, HIV protease inhibitors) within 4 days prior to randomization and during the study.

Outcome results