Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

NCT00395772 | Completed Phase 2

• 2 other identifiers: 11528EudraCT: 2004-002171-16
• Study Type: interventional
• Target: 543
• Locations: 13 countries
• Sites: 78

Brief Summary

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

Conditions

Venous Thromboembolism

Keywords

Treatment of venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks.

  12 weeks

Secondary Outcomes (2)

• The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks.

  12 weeks

• The separate components of the primary efficacy outcome at 12 weeks.

  12 weeks

Study Arms (4)

Arm 4

ACTIVE COMPARATOR

Drug: (LMW) Heparin + Vitamin K Antagonist

Arm 1

EXPERIMENTAL

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 2

EXPERIMENTAL

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 3

EXPERIMENTAL

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Interventions

Xarelto (Rivaroxaban, BAY59-7939) DRUG

BAY59-7939 20 mg once daily (od) for 12 weeks

Arm 1

(LMW) Heparin + Vitamin K Antagonist DRUG

Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks

Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent

You may not qualify if:

• Legal lower age limitations (country specific)
• Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
• Other indication for VKA than PE/DVT
• More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
• Participation in another pharmacotherapeutic study within the prior 30 days
• Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis
• Life expectancy \< 3 months
• Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin
• Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg
• Pregnancy or childbearing potential without proper contraceptive measures
• Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
• Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study

Sponsors & Collaborators

• Bayer: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (78)

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Albuquerque, New Mexico, 87108-4763, United States

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Albuquerque, New Mexico, 87131, United States

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Chapel Hill, North Carolina, 27599-7065, United States

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Fredericksburg, Virginia, 22401, United States

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Seattle, Washington, 98122, United States

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Canberra, Australian Capital Territory, 2605, Australia

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Sydney, New South Wales, 2065, Australia

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Sydney, New South Wales, 2217, Australia

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Brisbane, Queensland, 4102, Australia

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Melbourne, Victoria, 3128, Australia

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Melbourne, Victoria, 3168, Australia

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Melbourne, Victoria, 3181, Australia

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Curitiba, Paraná, 80050-350, Brazil

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Porto Alegre, Rio Grande do Sul, 90470 340, Brazil

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São Paulo, São Paulo, 01323-001, Brazil

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Sorocaba, São Paulo, 18031-000, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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London, Ontario, N6A 5A5, Canada

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Hradec Králové, 500 05, Czechia

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Karlovy Vary, 360 66, Czechia

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Ostrava, 708 52, Czechia

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Pilsen, 323 33, Czechia

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Prague, 10034, Czechia

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Prague, 150 06, Czechia

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Ústí nad Labem, 401 13, Czechia

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Aarhus, 8000, Denmark

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Brædstrup, 8740, Denmark

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Frederiksberg, 2000, Denmark

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Brest, 29609, France

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Grenoble, 38043, France

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Montpellier, 34295, France

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Paris, 75475, France

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Paris, 75908, France

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Saint-Etienne, 42055, France

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Valenciennes, 59322, France

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Afula, 18101, Israel

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Ashkelon, 78306, Israel

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Haifa, 31048, Israel

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Haifa, 31096, Israel

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Haifa, 34362, Israel

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Holon, 58100, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Safed, 13100, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Milan, 20122, Italy

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Milan, 20132, Italy

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Milan, 20142, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Reggio Emilia, 42100, Italy

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Venezia, 30122, Italy

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Amersfoort, 3818 ES, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Arnhem, 6815 AD, Netherlands

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Groningen, 9713 GZ, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Maastricht, 6229 HX, Netherlands

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Sittard-geleen, 6162 BG, Netherlands

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Zwolle, 8025 AB, Netherlands

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Warsaw, Poland, 02-097, Poland

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Bydgoszcz, 85-168, Poland

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Warsaw, 01-138, Poland

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Wroclaw, 50-367, Poland

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Wroclaw, 51-124, Poland

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Johannesburg, Gauteng, 2132, South Africa

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Johannesburg, Gauteng, 2157, South Africa

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Johannesburg, Gauteng, 2191, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Johannesburg, Gauteng, South Africa

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Gothenburg, 416 85, Sweden

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Jönköping, 551 85, Sweden

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Stockholm, 118 83, Sweden

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Stockholm, 171 76, Sweden

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Västervik, 593 81, Sweden

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Related Publications (1)

• Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, Misselwitz F, Raskob G, Schellong S, Segers A; Einstein-DVT Dose-Ranging Study investigators. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008 Sep 15;112(6):2242-7. doi: 10.1182/blood-2008-05-160143. Epub 2008 Jul 11.

  PMID: 18621928 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Heparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 3, 2006
• Study Start: December 1, 2004
• Study Completion: December 1, 2005
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

SE (5); US (5); CA (3); BR (4); PL (5); IT (7); DK (3); CZ (7); NL (9); IL (11); ZA (5); AU (7); FR (7)