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

NCT01516840 | Completed Phase 3 DMC

• 1 other identifier: 14568
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 29

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.

Conditions

Deep Vein Thrombosis

Keywords

acute symptomatic deep vein thrombosis

Outcome Measures

Primary Outcomes (2)

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

  Up to 12 months

• Number of clinically relevant bleedings

  Up to 2 days after last dose

Secondary Outcomes (3)

• Number of participants with improvement in thrombotic burden

  At week 3

• Number of participants with deterioration in thrombotic burden

  Up to 12 months

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

  Up to 12 months

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Arm 2

EXPERIMENTAL

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Arm 3

ACTIVE COMPARATOR

Drug: Unfractionated heparin

Arm 4

ACTIVE COMPARATOR

Drug: Warfarin

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

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

Arm 1

Unfractionated heparin DRUG

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

Arm 3

Warfarin DRUG

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

Arm 4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (29)

Unknown Facility

Toyoake, Aichi-ken, 470-1192, Japan

Location

Unknown Facility

Aomori, Aomori, 030-8553, Japan

Location

Unknown Facility

Sakura, Chiba, 285-8741, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-0001, Japan

Location

Unknown Facility

Maebashi, Gunma, 371-8511, Japan

Location

Unknown Facility

Ōtake, Hiroshima, 739-0696, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 006-8555, Japan

Location

Unknown Facility

Takarazuka, Hyōgo, 665-0827, Japan

Location

Unknown Facility

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 245-8575, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, 862-8505, Japan

Location

Unknown Facility

Tsu, Mie-ken, 514-8507, Japan

Location

Unknown Facility

Sasebo, Nagasaki, 857-8511, Japan

Location

Unknown Facility

Niigata, Niigata, 951-8520, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 701-1192, Japan

Location

Unknown Facility

Osaka, Osaka, 530-8480, Japan

Location

Unknown Facility

Osaka, Osaka, 537-8511, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Suita, Osaka, 565-8565, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, 424-8636, Japan

Location

Unknown Facility

Tokushima, Tokushima, 770-8503, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Unknown Facility

Chuoku, Tokyo, 104-8560, Japan

Location

Unknown Facility

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 152-8902, Japan

Location

Unknown Facility

Shinagawa, Tokyo, 141-8625, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 162-8655, Japan

Location

Unknown Facility

Wakayama, Wakayama, 640-8158, Japan

Location

Related Publications (2)

• 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.

  PMID: 25851062 DERIVED

• 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.

  PMID: 25717286 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban; Heparin; Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

JP (29)