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

Browse trials for

• Pulmonary Embolism 738
• Atrial Fibrillation 3,869
• Thrombosis 1,508
• Acute Coronary Syndrome 1,461
• Embolism 707
• Venous Thrombosis 774

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

Pulmonary Embolism

738 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.

This study's enrollment of 665,533 is above the median of 383 across 323 observational studies indexed under Pulmonary Embolism.

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Study population

Groups and cohorts

• Rivaroxaban

  Patients who have been prescribed Rivaroxaban for the first time

  Drug: Rivaroxaban (Xarelto, Bay59-7939)

• Standard of care

  Patients who have been prescribed Standard of care for the first time

  Drug: Standard of care

Interventions

• DrugRivaroxaban (Xarelto, Bay59-7939)

  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 \[bid\]).

• DrugStandard of care

  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

   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).

   Time frame: 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)

   Time frame: 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

   Time frame: 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.

   Time frame: 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.

   Time frame: up to 8 years

Secondary outcomes

1. 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

   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"

   Time frame: up to 8 years

2. Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care

   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

   Time frame: up to 8 years

3. Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care

   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

   Time frame: up to 8 years

4. Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care

   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.

   Time frame: up to 8 years

5. Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care

   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

   Time frame: up to 8 years

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

   Deaths can be identified from core data and hospital data

   Time frame: up to 8 years