Venous ThromboembolismNCT04444804
Study to Compare the Effectiveness of Rivaroxaban (Xarelto) Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism in Routine Clinical Practice in Germany
An observational study of Venous Thromboembolism, run by Bayer at 1 site in Germany.
Trial summary
Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. 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, BAY 59-7939) and LMWH and Phenprocoumon
- How many people
- 22,153 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2020to 30 Apr 2021
- 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: The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.
Who may be able to join
- At least one new diagnosis of VTE during the inclusion period:
- Ambulatory diagnosis, coded as verified,
- Primary hospital discharge diagnosis.
- Secondary hospital discharge diagnosis The quarter of the first VTE diagnosis in the inclusion period will be defined as the index quarter. For hospital diagnoses, the date of admission will be used to define the index quarter.
- The 12 months prior to the index date will define the baseline period for all included patients. Patients treated with anticoagulation regimens other than defined above (e.g. other DOACs) will not be included in the study. All patients will have to fulfill the additional inclusion criteria:
- Continuous enrolment in the baseline period
- ≥ 18 years of age at index date
Who cannot join
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of VTE in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of atrial fibrillation in the baseline period; Individuals with documented cardiac valve surgery in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis indicating pregnancy in the baseline period;
- A prescription of any anticoagulation treatment (heparins; vitamin-K antagonists; rivaroxaban; other DOACs) in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period;
- A prescription of contraindicated drug for rivaroxaban due to drug interactions (i.e. azole antifungals and HIV protease inhibitors) in the 60 days before or on the index date.
- Patients assigned to rivaroxaban exposure groups who were initially treated with a dose strength other than 15 mg or 20 mg per tablet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Comparative Effectiveness of Rivaroxaban Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism (RECENT)
Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban (Xarelto, BAY 59-7939), LMWH and Phenprocoumon
- 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, BAY 59-7939)Drug
Dosage at the discretion of the treating physician
LMWH and PhenprocoumonDrug
Dosage at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database. Receives: Drug: Rivaroxaban (Xarelto, BAY 59-7939) | |
| Low-molecular-weight heparin (LMWH) and Phenprocoumon | The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database. Receives: Drug: LMWH and Phenprocoumon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
A recurrent VTE event will be defined as a hospitalization with a primary hospital discharge diagnoses for VTE for which the admission date was >14 days after the index date.
Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.
Measured: Retrospective data from January 2013 to December 2018
Secondary outcomes (1)
Risk of fatal bleeding in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
Cases of fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.
Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.
Measured: Retrospective data from January 2013 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start31 Jul 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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
- 22,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444804
- Sponsor's protocol ID
- 21456
- Status last verified
- Apr 2022
- First submitted
- 22 Jun 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Comparative Effectiveness of Rivaroxaban Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism (RECENT)
- ClinicalTrials.gov ID
- NCT04444804
- Acronym / sponsor ID
- 21456
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,153 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Jun 2020 (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.
Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY 59-7939)The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database. |
| Low-molecular-weight heparin (LMWH) and Phenprocoumon | – | Drug: LMWH and PhenprocoumonThe source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.
Key inclusion criteria (7 listed)
- At least one new diagnosis of VTE during the inclusion period:
- Ambulatory diagnosis, coded as verified,
- Primary hospital discharge diagnosis.
- Secondary hospital discharge diagnosis The quarter of the first VTE diagnosis in the inclusion period will be defined as the index quarter. For hospital diagnoses, the date of admission will be used to define the index quarter.
- The 12 months prior to the index date will define the baseline period for all included patients. Patients treated with anticoagulation regimens other than defined above (e.g. other DOACs) will not be included in the study. All patients will have to fulfill the additional inclusion criteria:
Key exclusion criteria (7 listed)
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of VTE in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of atrial fibrillation in the baseline period; Individuals with documented cardiac valve surgery in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis indicating pregnancy in the baseline period;
- A prescription of any anticoagulation treatment (heparins; vitamin-K antagonists; rivaroxaban; other DOACs) in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline 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, BAY 59-7939)Dosage at the discretion of the treating physician | Drug | Rivaroxaban |
| LMWH and PhenprocoumonDosage at the discretion of the treating physician | Drug | Low-molecular-weight heparin (LMWH) and Phenprocoumon |
Primary outcome
Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
Time frame: Retrospective data from January 2013 to December 2018
A recurrent VTE event will be defined as a hospitalization with a primary hospital discharge diagnoses for VTE for which the admission date was >14 days after the index date. Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.
1 secondary outcome
Risk of fatal bleeding in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
Time frame: Retrospective data from January 2013 to December 2018
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 28 Apr 2022.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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 Germany.
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 7 inclusion and 7 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 28 Apr 2022. 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 Germany. 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?
Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon (time frame: Retrospective data from January 2013 to December 2018). 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 28 Apr 2022.