check_circleStudy Completed

Venous thromboembolism

Bayer Identifier:

17522

ClinicalTrials.gov Identifier:

NCT02558465

EudraCT Number:

Not Available

EU CT Number:

Not Available
Special Drug Use Investigation of Xarelto for Venous thromboembolism (VTE)

Trial purpose

The objective of this investigation is to assess safety
and effectiveness of Xarelto under practice routine use
in VTE secondary prevention after acute DVT, focusing
on hemorrhagic-related AEs, recurrent venous
thromboembolism (PE/DVT), all-cause mortality.
This study is a company sponsored, one- arm
prospective cohort study with patients to whom
Rivaroxaban treatment for VTE (PE/DVT) has been
chosen.
The study includes a standard observation period (1
year) and an extension survey period (2 years, at the
longest).

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.
  • - Patients who are contraindicated based on the product label and have already received Xarelto treatment.

Trial summary

Enrollment Goal
2540
Trial Dates
November 2015 - May 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Japan

Primary Outcome

  • Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Composite number of all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), clinically relevant non-major bleeding and all other adverse events/ADRs
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with asymptomatic deterioration of thrombotic burden (change of D-dimer, imaging test such as CT or CCUS) by the end of standard observation period
    date_rangeTime Frame:
    at 1 year
    enhanced_encryption
    Safety Issue:
    Yes
  • Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Special Drug Use Investigation of Xarelto for VTE
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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