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Completed

NCT Number: NCT02468102

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

This prospective cohort study will provide information about:

Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time.

The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

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Key information

Conditions

Acute Coronary Syndrome Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Digestive System Diseases Embolism Embolism and Thrombosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Heart Diseases Hemorrhage Intracranial Hemorrhages Lung Diseases Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in Sweden, between December 9, 2011 and December 31, 2018

Exclusion criteria

  • For the AF and DVT/PE treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between July 1, 2005 and December 9, 2011 will be excluded

Treatment and study plan

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 drugs

Drug

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.

Primary outcomes

  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

    Time frame: 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)

  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

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. Occurrence of non-infective liver disease (secondary safety outcome) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.

    Time frame: 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.

  3. Outcomes related to effectiveness (DVT/PE, ischaemic stroke or myocardial infarction) in individuals receiving rivaroxaban in comparison with those receiving current standard of care.

    Time frame: 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.

  4. All-cause mortality as well as cause-specific mortality.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 10, 2015
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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