An observational study in Pulmonary Embolism, sponsored by Bayer. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-27.
Sponsored by Bayer · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 15 studies in Pulmonary Embolism by Bayer — none open to participants now, none under way, none of them phase 3. Pulmonary Embolism · Bayer.
Among the 15 studies in Pulmonary Embolism by Bayer, this one is the only one that started in 2018, is one of 9 observational ones, and was the 15th registered.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
Browse Pulmonary Embolism studies →None of the 15 studies in Pulmonary Embolism by Bayer is open now. The open studies under Pulmonary Embolism, anywhere →
Of the 129 Pulmonary Embolism studies recruiting now, 109 (84%) set no upper age limit and 5 (4%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 288 is below the median of 361 across 366 observational studies indexed under Pulmonary Embolism.
Median enrollment 1,989 across the 6 interventional studies, 1,987 across the 9 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Pulmonary Embolism by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited. Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China.
Patients treated in Tertiary hospitals
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anticoagulation with rivaroxaban
Drug: Rivaroxaban(Xarelto, BAY 59-7939)
The dosage and the anticoagulation duration is decided by investigators. As list in product information, the PE treatment dosage of rivaroxaban is 15mg bid for first 21 days and then 20mg qd. If CrCl is 30-49 ml/min and bleeding risk is over VTE recurrence risk, 20mg qd can be replaced with 15mg qd.
Major bleedings
Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal; or death.
Time frame: Up to 12 months
Symptomatic recurrent venous thromboembolic events
Will be confirmed by objective diagnostic tools, such as compression ultrasound, venography, CT scan or ventilation/perfusion lung scan, according to the real clinical practice.
Time frame: Up to 12 months
Major adverse cardiac events
Including myocardial infarction and cardiac death
Time frame: Up to 12 months
Other symptomatic thromboembolic events
As defined by Standardized MedDRA Query 'Embolic and thrombotic events
Time frame: Up to 12 months
Drug utilization
Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications
Time frame: Up to 12 months
Number of participants with adverse events and serious adverse events
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE is serious (SAE) if it: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization (see exceptions below) * Results in persistent or significant disability or incapacity * Is a congenital anomaly or birth defect * Is medically important.
Time frame: Up to 12 months
Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)
The Anti-Clot Treatment Scale (ACTS) is a 17-item patient-reported measure of satisfaction with anticoagulant treatment. It includes 13 items about the burdens and 4 items about the benefit of ACT.
Time frame: Up to 12 months
Plan to share: No — Availability of this study's data will later 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.vivli.org 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 member section of the portal.
Ran from Feb 2018 to primary completion in Jul 2021, 41 months.
Of 160 observational studies under Pulmonary Embolism, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 105. This study's 41 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.