Venous ThromboembolismNCT03214172
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban
An observational study of Venous Thromboembolism, run by Bayer at 1 site in United States.
Trial summary
To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2017to 15 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases is used. The Truven Health MarketScan® Research Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. Individuals enrolled in the MarketScan databases are largely representative of the United States population in terms of age, sex, and type of health insurance coverage. The data come from a selection of large employers, health plans, and government and public organizations and contain claims from approximately 100 employers, health plans, and government and public organizations representing about 50 million covered lives across all age groups. The data elements to be used in the proposed study will include health plan enrollment records, participant demographics, inpatient and outpatient medical claims and outpatient prescription drug dispensing records.
Who may be able to join
- Adult patients (≥18 years-of-age) with active cancer
- Patient with at least one index venous thromboembolism (VTE )
- ≥6-months of continuous eligibility prior to the index VTE event (baseline period).
- Newly initiated on rivaroxaban
Who cannot join
- Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date
- Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period
Trial locations and contacts
1 site in 1 country.
About this study
To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
15/20 mg
| Study group | Role | What they receive |
|---|---|---|
| Cancer-associated thrombosis | Adult patients with active cancer with at least one index venous thromboembolism (VTE) and no anticoagulation use during the 6-months (baseline period) prior to the index VTE event Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Venous thromboembolism
Derived using inpatient and outpatient medical claims
Measured: Retrospective analysis from November 2012 through September 2015
Bleeding (based on the Cunningham algorithm)
Derived using inpatient and outpatient medical claims
Measured: Retrospective analysis from November 2012 through September 2015
Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims)
Derived using inpatient and outpatient medical claims
Measured: Retrospective analysis from November 2012 through September 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start15 Jul 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214172
- Sponsor's protocol ID
- 19622
- Status last verified
- Sep 2018
- First submitted
- 9 Jul 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban
- ClinicalTrials.gov ID
- NCT03214172
- Acronym / sponsor ID
- 19622
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer-associated thrombosis | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Adult patients with active cancer with at least one index venous thromboembolism (VTE) and no anticoagulation use during the 6-months (baseline period) prior to the index VTE event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases is used. The Truven Health MarketScan® Research Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. Individuals enrolled in the MarketScan databases are largely representative of the United States population in terms of age, sex, and type of health insurance coverage. The data come from a selection of large employers, health plans, and government and public organizations and contain claims from approximately 100 employers, health plans, and government and public organizations representing about 50 million covered lives across all age groups. The data elements to be used in the proposed study will include health plan enrollment records, participant demographics, inpatient and outpatient medical claims and outpatient prescription drug dispensing records.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years-of-age) with active cancer
- Patient with at least one index venous thromboembolism (VTE )
- ≥6-months of continuous eligibility prior to the index VTE event (baseline period).
- Newly initiated on rivaroxaban
Key exclusion criteria (2 listed)
- Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date
- Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)15/20 mg | Drug | Cancer-associated thrombosis |
Primary outcome
Recurrent Venous thromboembolism
Time frame: Retrospective analysis from November 2012 through September 2015
Derived using inpatient and outpatient medical claims
Bleeding (based on the Cunningham algorithm)
Time frame: Retrospective analysis from November 2012 through September 2015
Derived using inpatient and outpatient medical claims
Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims)
Time frame: Retrospective analysis from November 2012 through September 2015
Derived using inpatient and outpatient medical claims
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Venous thromboembolism (time frame: Retrospective analysis from November 2012 through September 2015). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.