Trial · NCT01947959
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)
NCT01947959, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany). Trials, record NCT01947959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01947959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)
- NCT number
- NCT01947959
- Status
- Completed
- Enrollment
- 665,533 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
- Interventions
- Rivaroxaban (Xarelto, Bay59-7939), Standard of care
- First posted
- 2013-09-23
- Last updated
- 2021-10-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time | up to 8 years | Age and sex distribution Proportion of patients defined as naïve, non-naïve, recent switchers and distant switchers Type and estimated duration of other anticoagulant use among the non-naïve group and for all patients Number of pregnancies and pregnancy outcomes' Use of specific prescribed medications confirming ACS indication Use of other prescribed medications Comorbidity based on inpatient and outpatient diagnoses Renal disease based on in- and outpatient diagnoses Healthcare utilization (e.g. number of hospital admissions). |
| Primary | Characteristics of rivaroxaban use in comparison with standard of care | up to 8 years | Estimated dose of index drug at index date and estimated duration of treatment Where available, the diagnosis associated with the prescribing of the index drug (where not available, estimated dose and duration of index drug will be used as a proxy for the associated diagnosis among rivaroxaban users) Dispensed amount (can be used to estimate duration of treatment) |
| Primary | Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care | up to 8 years | Cases of intracranial haemorrhage will be identified in hospitalized patients with a discharge diagnosis of intracranial haemorrhage that meet the criteria for one of the three following categories: Incident cases of intracerebral haemorrhage Incident cases of subarachnoid haemorrhage Incident cases of epidural, dural, subdural and arachnoid haemorrhage |
| Primary | Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care | up to 8 years | A patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding: A hospital admission with a discharge diagnosis of gastrointestinal bleeding, i.e. a bleeding riginating in the upper or lower gastrointestinal tract or, more specifically, in the oesophagus, stomach, duodenum, jejunum, ileum, colon or rectum. For upper gastrointestinal bleeding: the lesion type being erosion, gastritis, duodenitis or peptic (gastric or duodenal) ulcer. |
| Primary | Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care | up to 8 years | A patient will have to meet the following criteria to be considered a case of urogenital bleeding: A hospital admission with a discharge diagnosis of urogenital bleeding. |
| Secondary | Safety: occurrence of bleeding events leading to hospitalization not specified as primary safety outcomes ("other bleeding") in individuals receiving rivaroxaban, in comparison with those receiving current standard of care | up to 8 years | A patient will have to meet the following criteria to be considered a case of "other bleeding": A hospital admission with a discharge diagnosis of "other bleeding" |
| Secondary | Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care | up to 8 years | A patient will have to meet all of the following criteria to be considered a case of non-infective liver disease: A hospital admission with a discharge diagnosis of acute liver injury. No diagnosis of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease, or alcoholism |
| Secondary | Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care | up to 8 years | A patient will have to meet the following criteria to be considered a case of DVT or PE: A hospital admission with a discharge diagnosis of DVT or PE, or an ambulatory diagnosis of DVT with a dispensation of another antithrombotic agent |
| Secondary | Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care | up to 8 years | A patient will have to meet the following criteria to be considered a case of ischaemic stroke: A hospital admission with a main discharge diagnosis of ischaemic stroke. |
| Secondary | Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care | up to 8 years | A patient will have to meet all of the following criteria to be considered a case of acute myocardial infarction: A hospital admission with a main discharge diagnosis of acute MI |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01947959
GET https://conductscience.org/api/trials/v1/NCT01947959/registered