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

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 2 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: All patients aged 2 years and above who have been enrolled in German Pharmacoepidemiological Research Database (GePaRD) for at least one year.

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 Pratice in Germany

Conditions

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

Being tested

Rivaroxaban (Xarelto, Bay59-7939), Standard of care

Keywords

Rivaroxaban, Stroke Prevention in Atrial Fibrillation, Anticoagulants, Hematologic Agents, Therapeutic Uses, Observational, Venous Thromboembolism, Secondary Prevention of Acute Coronary Syndrome, Intracranial Hemorrhages, Gastrointestinal Hemorrhage

Medical subject headings

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

  The treatment of DVT or PE, and prevention of recurrent DVT and PE in adult patients (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).

  The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors (20 mg rivaroxaban [od], tablets).

  The prevention of venous thromboembolism (VTE) in adult 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 adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid]).

• Standard of careDrug

  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

   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).

   Measured: up to 8 years

2. Characteristics of rivaroxaban use in comparison with standard of care

   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)

   Measured: up to 8 years

3. Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care

   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

   Measured: up to 8 years

4. Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care

   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.

   Measured: up to 8 years

5. Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care

   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.

   Measured: up to 8 years

Timeline

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

1. First posted23 Sep 2013 (estimated)
2. Study start22 Dec 2011
3. Primary completion30 Sep 2020
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 Venous ThrombosisStudies 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.