check_circleStudy Completed
Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation, Acute Coronary Syndrome
Bayer Identifier:
16647
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice (UK)
Trial purpose
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 Warfarin for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.
Key Participants Requirements
Sex
BothAge
2 - N/ATrial summary
Enrollment Goal
50299Trial Dates
December 2011 - September 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, United Kingdom |
Primary Outcome
- 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 timedate_rangeTime Frame:Up to 8 yearsenhanced_encryptionYesSafety Issue:
- Characteristics of rivaroxaban use in comparison with standard of caredate_rangeTime Frame:Up to 8 yearsenhanced_encryptionNoSafety Issue:
- Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of careCases of intracranial haemorrhage will be identified in patients referred to a specialist or admitted to hospital that meet the criteria for one of the three following categories: • incident cases of intracerebral haemorrhage recorded following or in association with computed tomography, magnetic resonance imaging (MRI) or X-ray angiography, or an appropriate therapeutic procedure. • incident cases of subarachnoid haemorrhage recorded following computed tomography, MRI, Xray angiography or lumbar puncture, or an appropriate therapeutic procedure. • incident cases of epidural, dural, subdural and arachnoid haemorrhage recorded following computed tomography, MRI, X-ray angiography or lumbar puncture, or an appropriate therapeutic procedure.date_rangeTime Frame:Up to 8 years
- Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of careA patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding: • the specific site of bleeding originating 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 • the lesion type being NOT related to cancer • the patient having been referred to a specialist or admitted to hospital.date_rangeTime Frame:Up to 8 years
- Safety: occurrence urogenital bleeding leading to hospitalizationA patient will have to meet both of the following criteria to be considered a case of urogenital bleeding: • the specific site of bleeding originating in the urogenital tract. • the patient having been referred to a specialist or admitted to hospital.date_rangeTime Frame:Up to 8 years
Secondary Outcome
- 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 careA patient will have to meet the following criteria to be considered a case of “other bleeding”: • admitted to hospital with a bleeding event occurring before hospitalization (i.e. excluding inhospital bleeding events).date_rangeTime Frame:Up to 8 yearsenhanced_encryptionYesSafety Issue:
- 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: • an increase of more than three times the upper limit of the normal range in alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or a combined increase in ALT, AST or alkaline phosphatase and total bilirubin, provided one of them is twice the upper limit of the respective normal range. • the patient having been referred to a specialist or admitted to hospital. • free of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease and alcoholism.date_rangeTime Frame:Up to 8 yearsenhanced_encryptionNoSafety Issue:
- 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: the patient having been admitted to hospital with a diagnosis of DVT or PEdate_rangeTime Frame:Up to 8 years
- Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of careA patient will have to meet the following criteria to be considered a case of ischaemic stroke: the patient having been admitted to hospital with a diagnosis of ischaemic stroke.date_rangeTime Frame:Up to 8 years
- Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of careA patient will have to meet the following criteria to be considered a case of MI: the patient having been admitted to hospital with a diagnosis of MIdate_rangeTime Frame:Up to 8 years
- All-cause mortality as well as cause-specific mortalityFor ascertainment of mortality automatic computer searches will be performed, based on: • Read Codes • Death certification incorporated in The Health Information Network (THIN) • Registration status of the patient recorded in THINdate_rangeTime Frame:Up to 8 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A