Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)

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 Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Residents of Sweden: The study population will be identified using data from the Swedish national health registers that are maintained by the national Board of Health and Welfare.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden

Conditions

Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation

Being tested

Rivaroxaban (Xarelto, BAY59-7939), Standard of care drugs

Keywords

Rivaroxaban, Venous Thrombosis/Pulmonary Embolism, Stroke Prevention in Atrial Fibrillation, Anticoagulants, Hematologic Agents, Therapeutic Uses, Observational, Pulmonary Embolism, Venous Thrombosis, Venous Thromboembolism, Intracranial Hemorrhages, Gastrointestinal Hemorrhage

Medical subject headings

Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Venous Thromboembolism, Intracranial Hemorrhages, Gastrointestinal Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Rivaroxaban (Xarelto, BAY59-7939)Drug

  Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).

  Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors, prior stroke or transient ischaemic attack (20 mg rivaroxaban [od], tablets).

  Prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).

  Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid]).

• Standard of care drugsDrug

  For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   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)

   Measured: up to 4 years

2. 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

   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.

   Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Jun 2015 (estimated)
2. Study start15 Jun 2015
3. Primary completion31 Dec 2018
4. Study completion30 Sep 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Acute Coronary SyndromeStudies 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.