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Venous ThromboembolismPhase 2NCT00395772

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

A Phase 2 study testing Xarelto (Rivaroxaban, BAY59-7939) and (LMW) Heparin + Vitamin K Antagonist in people with Venous Thromboembolism, run by Bayer at 78 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Xarelto (Rivaroxaban, BAY59-7939) and (LMW) Heparin + Vitamin K Antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
543 participants
Where
78 sitesin 13 countries
Study dates
Dec 2004to Dec 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

78 sites in 13 countries.

78 sites in 13 countries

Israel11 sites

  • Study site

    Afula, 18101

  • Study site

    Ashkelon, 78306

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 31096

  • Study site

    Haifa, 34362

  • Study site

    Holon, 58100

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49100

  • Study site

    Safed, 13100

  • Study site

    Tel Aviv, 64239

  • Study site

    Tel HaShomer, 52621

Other trials in Israel

Netherlands9 sites

  • Study site

    Amersfoort, 3818 ES

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Arnhem, 6815 AD

  • Study site

    Groningen, 9713 GZ

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Maastricht, 6229 HX

  • Study site

    Sittard-geleen, 6162 BG

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Australia7 sites

  • Study site

    Brisbane, Queensland, 4102

  • Study site

    Canberra, Australian Capital Territory, 2605

  • Study site

    Melbourne, Victoria, 3128

  • Study site

    Melbourne, Victoria, 3168

  • Study site

    Melbourne, Victoria, 3181

  • Study site

    Sydney, New South Wales, 2065

  • Study site

    Sydney, New South Wales, 2217

Other trials in Australia

Czechia7 sites

  • Study site

    Hradec Králové, 500 05

  • Study site

    Karlovy Vary, 360 66

  • Study site

    Ostrava, 708 52

  • Study site

    Pilsen, 323 33

  • Study site

    Prague, 10034

  • Study site

    Prague, 150 06

  • Study site

    Ústí nad Labem, 401 13

Other trials in Czechia

France7 sites

  • Study site

    Brest, 29609

  • Study site

    Grenoble, 38043

  • Study site

    Montpellier, 34295

  • Study site

    Paris, 75475

  • Study site

    Paris, 75908

  • Study site

    Saint-Etienne, 42055

  • Study site

    Valenciennes, 59322

Other trials in France

Italy7 sites

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Milan, 20142

  • Study site

    Padova, 35128

  • Study site

    Pavia, 27100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Venezia, 30122

Other trials in Italy

United States5 sites

  • Study site

    Albuquerque, New Mexico, 87108-4763

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Chapel Hill, North Carolina, 27599-7065

  • Study site

    Fredericksburg, Virginia, 22401

  • Study site

    Seattle, Washington, 98122

Other trials in United States

Poland5 sites

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Warsaw, Poland, 02-097

  • Study site

    Warsaw, 01-138

  • Study site

    Wroclaw, 50-367

  • Study site

    Wroclaw, 51-124

Other trials in Poland

South Africa5 sites

  • Study site

    Johannesburg, Gauteng, 2132

  • Study site

    Johannesburg, Gauteng, 2157

  • Study site

    Johannesburg, Gauteng, 2191

  • Study site

    Johannesburg, Gauteng, 2193

  • Study site

    Johannesburg, Gauteng

Other trials in South Africa

Sweden5 sites

  • Study site

    Gothenburg, 416 85

  • Study site

    Jönköping, 551 85

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 171 76

  • Study site

    Västervik, 593 81

Other trials in Sweden

Brazil4 sites

  • Study site

    Curitiba, Paraná, 80050-350

  • Study site

    Porto Alegre, Rio Grande do Sul, 90470 340

  • Study site

    São Paulo, São Paulo, 01323-001

  • Study site

    Sorocaba, São Paulo, 18031-000

Other trials in Brazil

Canada3 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    London, Ontario, N6A 5A5

Other trials in Canada

Denmark3 sites

  • Study site

    Aarhus, 8000

  • Study site

    Brædstrup, 8740

  • Study site

    Frederiksberg, 2000

Other trials in Denmark

About this study

Official title: Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.

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.

Read the detailed description

Within the U.S., Johnson \& Johnson is sponsor.

Being tested
Xarelto (Rivaroxaban, BAY59-7939), (LMW) Heparin + Vitamin K Antagonist
Keywords
Treatment of venous thromboembolism
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

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

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

    BAY59-7939 30 mg od for 12 weeks

  • Xarelto (Rivaroxaban, BAY59-7939)Drug

    BAY59-7939 40 mg od for 12 weeks

  • (LMW) Heparin + Vitamin K AntagonistDrug

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

Study groups in NCT00395772
Study groupRoleWhat they receive
Arm 4Active comparatorNot described
Receives: Drug: (LMW) Heparin + Vitamin K Antagonist
Arm 1ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 2ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 3ExperimentalNot described
Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (2)

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

    Measured: 12 weeks

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2006 (estimated)
  2. Study startDec 2004
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00395772
Sponsor's protocol ID
11528
Other IDs
EudraCT: 2004-002171-16
Status last verified
Oct 2014
First submitted
2 Nov 2006
Last updated
28 Oct 2014
Results posted
No

Publications

  • 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.

    PubMed 18621928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Xarelto (Rivaroxaban, BAY59-7939) and (LMW) Heparin + Vitamin K Antagonist in people with Venous Thromboembolism, run by Bayer at 78 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Israel, Netherlands, Australia, Czechia, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00395772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.

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