Clinical trial NCT01516840: Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Keywords: acute symptomatic deep vein thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2012-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 acute symptomatic DVT without symptomatic PE.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
timeFrame: Up to 12 months
measure: Number of clinically relevant bleedings
timeFrame: Up to 2 days after last dose
Secondary outcomes:
measure: Number of participants with improvement in thrombotic burden
timeFrame: At week 3
measure: Number of participants with deterioration in thrombotic burden
timeFrame: Up to 12 months
measure: Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Toyoake
country: Japan
state: Aichi
city: Sakura
country: Japan
state: Chiba
city: Maebashi
country: Japan
state: Gunma
city: Otake
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Takarazuka
country: Japan
state: Hyogo
city: Kahoku-gun
country: Japan
state: Ishikawa
city: Kanazawa
country: Japan
state: Ishikawa
city: Yokohama
country: Japan
state: Kanagawa
city: Tsu
country: Japan
state: Mie
city: Sasebo
country: Japan
state: Nagasaki
city: Osakasayama
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chuoku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Aomori
country: Japan
city: Fukuoka
country: Japan
city: Kumamoto
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
city: Tokushima
country: Japan
city: Wakayama
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.