UMIN ID: UMIN000025072
Registered date:30/11/2016
Japanese registry of Rivaroxaban effectiveness & safety for the prevention of recurrence in patients with Deep Vein Thrombosis and Pulmonary Embolism
Basic Information
| Recruitment status | Open public recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Deep Vein Thrombosis and Pulmonary Embolism |
| Date of first enrollment | 2016/12/01 |
| Target sample size | 1000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Recurrence/exacerbation of symptomatic venous thromboembolism (VTE) |
|---|---|
| Secondary Outcome | ･ Onset/exacerbation of symptomatic pulmonary embolism (PE) ･ Onset/exacerbation of symptomatic deep vein thrombosis (DVT) ･ Major bleeding event (ISTH bleeding criteria) ･ Non-major bleeding event (bleeding events that do not correspond to major bleeding) ･ Recurrence/exacerbation of symptomatic venous thromboembolism or bleeding event during the initial strengthening treatment period ･ Acute coronary syndrome ･ Cerebral infarction ･ VTE related death ･ Cardiovascular death ･ All deaths ･ Relationship between change in D-dimer and recurrence ･ Comparison of examples of treatment continuation/discontinuation or termination events ･ Serious adverse events |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | Patients with symptomatic or asymptomatic venous thromboembolism prescribed rivaroxaban for the purpose of treatment and prevention of recurrence of acute deep vein thrombosis and pulmonary embolism |
| Exclude criteria | 1. Patients with a contraindication to rivaroxaban 2. Patients with chronic thromboembolic pulmonary hypertension (however, it is possible to register if there is coexisting acute pulmonary embolism or deep vein thrombosis) 3. Patients with active bleeding 4. In addition, patients determined to be inappropriate for the study by the attending doctor |
Related Information
| Primary Sponsor | Nihon University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Bayer Yakuhin, Ltd |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuki Nishiura |
| Address | Toranomon Towers Office, 4-1-28 Toranomon, Minato-ku, Tokyo Japan |
| Telephone | 0120-297-437 |
| jxactly@mebix.co.jp | |
| Affiliation | Mebix, Inc. Research Promotion Group |
| scientific contact | |
| Name | Atsushi Hirayama |
| Address | 30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo Japan |
| Telephone | 03-3972-8111 |
| hirayama.atsushi@nihon-u.ac.jp | |
| Affiliation | Nihon University School of Medicine Division of Cardiology, Department of Internal Medicine |