Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
NCT ID: NCT01516814
Last Updated: 2017-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2012-02-29
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
NCT01516840
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
NCT02558465
A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Database
NCT04923139
Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients With Deep Vein Thrombosis and Pulmonary Embolism
NCT03091621
Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy
NCT02210819
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily
Arm 2
Unfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
Arm 3
Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivaroxaban (Xarelto, BAY59-7939)
15 mg twice daily for 21 days, followed by 15 mg once daily
Unfractionated heparin
To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
Warfarin
To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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 PE 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Aomori, Aomori, Japan
Chiba, Chiba, Japan
Sakura, Chiba, Japan
Kurume, Fukuoka, Japan
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Kahoku-gun, Ishikawa-ken, Japan
Kanazawa, Ishikawa-ken, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Tsu, Mie-ken, Japan
Matsumoto, Nagano, Japan
Suwa, Nagano, Japan
Niigata, Niigata, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Sayama, Osaka, Japan
Suita, Osaka, Japan
Saga, Saga-ken, Japan
Shizuoka, Shizuoka, Japan
Shimotsuke, Tochigi, Japan
Bunkyo-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Chuoku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15960
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.