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Deep Vein ThrombosisPhase 3NCT01516840

Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin and Warfarin in people with Deep Vein Thrombosis, run by Bayer at 29 sites in Japan.

Completed

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

Official record
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Trial summary

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin and Warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
29 sitesJapan
Study dates
Mar 2012to Jan 2014
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)

Who cannot join

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
  • More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization
  • Calculated creatinine clearance (CLCR) < 30 mL/min
  • Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
  • Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
  • Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Japan29 sites

  • Study site

    Aomori, Aomori, 030-8553

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Chuoku, Tokyo, 104-8560

  • Study site

    Fukuoka, Fukuoka, 810-0001

  • Study site

    Kahoku-gun, Ishikawa-ken, 920-0293

  • Study site

    Kanazawa, Ishikawa-ken, 920-8650

  • Study site

    Kumamoto, Kumamoto, 862-8505

  • Study site

    Maebashi, Gunma, 371-8511

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Niigata, Niigata, 951-8520

  • Study site

    Okayama, Okayama-ken, 701-1192

  • Study site

    Osaka, Osaka, 530-8480

  • Study site

    Osaka, Osaka, 537-8511

  • Study site

    Ōtake, Hiroshima, 739-0696

  • Study site

    Sakura, Chiba, 285-8741

  • Study site

    Sapporo, Hokkaido, 006-8555

  • Study site

    Sasebo, Nagasaki, 857-8511

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Shinagawa, Tokyo, 141-8625

  • Study site

    Shinjuku-ku, Tokyo, 162-8655

  • Study site

    Shizuoka, Shizuoka, 424-8636

  • Study site

    Suita, Osaka, 565-8565

  • Study site

    tabashi City, Tokyo, 173-8610

  • Study site

    Takarazuka, Hyōgo, 665-0827

  • Study site

    Tokushima, Tokushima, 770-8503

  • Study site

    Toyoake, Aichi-ken, 470-1192

  • Study site

    Tsu, Mie-ken, 514-8507

  • Study site

    Wakayama, Wakayama, 640-8158

  • Study site

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

About this study

Official title: Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.

Read the detailed description

The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin, Warfarin
Keywords
acute symptomatic deep vein thrombosis
Medical subject headings
Venous Thrombosis

What participants receive

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

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    10 mg twice daily for 21 days, followed by 15 mg once daily

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    15 mg twice daily for 21 days, followed by 15 mg once daily

  • Unfractionated heparinDrug

    To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)

  • WarfarinDrug

    To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Study groups in NCT01516840
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 2ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 3Active comparatorNot described
Receives: Drug: Unfractionated heparin
Arm 4Active comparatorNot described
Receives: Drug: Warfarin

What is being measured

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

  1. Number of participants with newly onset of symptomatic venous thromboembolism (VTE)

    Measured: Up to 12 months

  2. Number of clinically relevant bleedings

    Measured: Up to 2 days after last dose

Secondary outcomes (3)

  1. Number of participants with improvement in thrombotic burden

    Measured: At week 3

  2. Number of participants with deterioration in thrombotic burden

    Measured: Up to 12 months

  3. Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus

    Measured: Up to 12 months

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2013
  4. Study completionJan 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516840
Sponsor's protocol ID
14568
Status last verified
Jan 2017
First submitted
20 Jan 2012
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Matsuo H, Prins M, Lensing AW, Fujinuma EW, Miyamoto Y, Kajikawa M. Shortened length of hospital stay with rivaroxaban in patients with symptomatic venous thromboembolism in Japan: the J-EINSTEIN pulmonary embolism and deep vein thrombosis program. Curr Med Res Opin. 2015 Jun;31(6):1057-61. doi: 10.1185/03007995.2015.1037728. Epub 2015 May 11.

    PubMed 25851062

  • Yamada N, Hirayama A, Maeda H, Sakagami S, Shikata H, Prins MH, Lensing AW, Kato M, Onuma J, Miyamoto Y, Iekushi K, Kajikawa M. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program. Thromb J. 2015 Jan 17;13:2. doi: 10.1186/s12959-015-0035-3. eCollection 2015.

    PubMed 25717286

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939), Unfractionated heparin and Warfarin in people with Deep Vein Thrombosis, run by Bayer at 29 sites in Japan.

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 1 inclusion and 6 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 NCT01516840, which also lists 2 linked publications.

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 18 Jan 2017.

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