Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients - Full Text View

Purpose

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

Condition	Intervention	Phase
Pulmonary Embolism	Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Unfractionated heparin Drug: Warfarin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Warfarin Warfarin sodium Heparin Rivaroxaban

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of participants with newly onset of symptomatic venous thromboembolism (VTE) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Number of clinically relevant bleedings [ Time Frame: Up to 2 days after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of participants with improvement in thrombotic burden [ Time Frame: At week 3 ] [ Designated as safety issue: No ]
Number of participants with deterioration in thrombotic burden [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	February 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Rivaroxaban (Xarelto, BAY59-7939) 15 mg twice daily for 21 days, followed by 15 mg once daily
Active Comparator: Arm 2	Drug: Unfractionated heparin To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
Active Comparator: Arm 3	Drug: Warfarin To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516814

Locations

Japan

Nagoya, Aichi, Japan, 457-8510

Toyoake, Aichi, Japan, 470-1192

Sakura, Chiba, Japan, 285-8741

Kurume, Fukuoka, Japan, 830-8543

Maebashi, Gunma, Japan, 371-8511

Sapporo, Hokkaido, Japan, 006-8555

Kahoku-gun, Ishikawa, Japan, 920-0293

Kanazawa, Ishikawa, Japan, 920-8650

Yokohama, Kanagawa, Japan, 245-8575

Tsu, Mie, Japan, 514-8507

Matsumoto, Nagano, Japan, 390-8510

Suwa, Nagano, Japan, 392-8510

Osakasayama, Osaka, Japan, 589-8511

Suita, Osaka, Japan, 565-8565

Shimotsuke, Tochigi, Japan, 329-0498

Bunkyo-ku, Tokyo, Japan, 113-8655

Bunkyo-ku, Tokyo, Japan, 113-8519

Chuoku, Tokyo, Japan, 104-8560

Itabashi-ku, Tokyo, Japan, 173-8610

Meguro-ku, Tokyo, Japan, 152-8902

Shinagawa, Tokyo, Japan, 141-8625

Shinjuku-ku, Tokyo, Japan, 162-8655

Aomori, Japan, 030-8553

Chiba, Japan, 260-8677

Kumamoto, Japan, 862-8505

Niigata, Japan, 951-8520

Osaka, Japan, 537-8511

Osaka, Japan, 553-0003

Osaka, Japan, 530-8480

Saga, Japan, 840-8571

Shizuoka, Japan, 424-8636

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier:	NCT01516814 History of Changes
Other Study ID Numbers:	15960
Study First Received:	January 20, 2012
Last Updated:	March 6, 2013
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:

acute symptomatic pulmonary embolism

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thrombosis
Thromboembolism

Calcium heparin
Heparin
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013