Trial · NCT02468102
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
NCT02468102, 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 (Sweden). Trials, record NCT02468102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02468102
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 (Sweden)
- NCT number
- NCT02468102
- Status
- Completed
- Enrollment
- 99,999 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care drugs
- First posted
- 2015-06-10
- Last updated
- 2021-09-27
Source ClinicalTrials.gov
Registered outcomes6
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 4 years | The following data will be collected and assessed at 2 and 4 years after rivaroxaban market authorization: • age and sex distribution at index date • dose of rivaroxaban at index date • diagnosis associated with the prescribing of the index drug • use of specific prescribed medications confirming ACS indication • use of other prescribed medications • comorbidity based on diagnoses • renal impairment • healthcare utilization (e.g. outpatient visits and hospital admissions) |
| Primary | Safety and effectiveness: occurrence of hospitalization for a) intracranial haemorrhage, (b) gastrointestinal bleeding, (c) urogenital bleeding among users of rivaroxaban in comparison with individuals receiving current standard of care | up to 5 years | The two cohorts will be followed up from the index date until 12 months after the end of the enrolment period for potential outcomes For descriptive purposes, annualized crude incidence rates of the major bleeding events will be calculated, accompanied by 95% confidence intervals. For evaluation of safety and effectiveness outcome events, Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication. |
| Secondary | Occurrence of hospitalization for bleeding events not specified as primary safety outcomes ("other bleeding", secondary safety outcome) in individuals receiving rivaroxaban, in comparison with those receiving current standard of care. | at 5 years | Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication. |
| Secondary | Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care. | at 5 years | Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication. |
| Secondary | Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care. | at 5 years | Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication. |
| Secondary | All-cause mortality as well as cause-specific mortality. | at 5 years | Outcome will be analyzed after end of data collection. Cox proportional hazards regression model will be used. Propensity score matching will be done to account for confounding by indication. |
Source ClinicalTrials.gov
Outcomes0
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/NCT02468102
GET https://conductscience.org/api/trials/v1/NCT02468102/registered