JRCT ID: jRCTs071180059
Registered date:19/03/2019
MARVEL-TTAS
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Deep vein thrombosis |
Date of first enrollment | 30/09/2019 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Administer 20mg/day apixaban (20mg/day) for 7days and 10mg/day apixaban following days as antithrombotic therapy for patients with deep vein thrombosis. |
Outcome(s)
Primary Outcome | Fluctuation of AR10-AU C30 value with or without bleeding events |
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Secondary Outcome | 1) Fluctuation of AR10-AUC30 value in the case of venous thromboembolism 2) Fluctuation of AR10-AUC30 value after the remission venous thromboembolism 3) All death 4) Other adverse events |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | New onset case of venous thromboembolism and deep vein thrombosis, who requires permanent antithrombotic therapy |
Exclude criteria | 1. contraindication of apixaban usage 2. Patients who are already taking antithrombotic or thrombolytic therapies 3. Patients who are judged as an inappropriate case to enroll |
Related Information
Primary Sponsor | Tsujita Kenichi |
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Secondary Sponsor | Arima Yuichiro |
Source(s) of Monetary Support | Bristol-Myers Squibb |
Secondary ID(s) |
Contact
Public contact | |
Name | Yuichiro Arima |
Address | 2-2-1 Honjo Chuo-ku Kumamoto city Kumamoto Japan 860-0811 |
Telephone | +81-96-373-6874 |
arimay@kumamoto-u.ac.jp | |
Affiliation | IRCMS |
Scientific contact | |
Name | Kenichi Tsujita |
Address | 1-1-1 Honjo Chuo-ku Kumamoto city Kumamoto Japan 860-8556 |
Telephone | +81-96-373-5175 |
tsujita@kumamoto-u.ac.jp | |
Affiliation | Kumamoto University Hospital |