Atrial Fibrillation (Prevention of Stroke) Clinical Trial
— RELIEFOfficial title:
REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation
| Verified date | November 2015 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: NA |
| Study type | Observational |
To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting
| Status | Completed |
| Enrollment | 8607 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age =18 years on the day of the first prescription of the study drug (= index date) during study selection window - Diagnosis of NVAF on start date of study or anytime during 365 days before this date - Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date) - Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window. Exclusion Criteria: - Patients with valvular AF - Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date - Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period - Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer | Janssen, LP |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI) | Composite cardiovascular endpoint | Within 1 year after treatment start | No |
| Secondary | Time to first occurrence of IS | Single cardiovascular event | Within 1 year after treatment start | No |
| Secondary | Time to first occurrence of TIA | Single cardiovascular event | Within 1 year after treatment start | No |
| Secondary | Time to first occurrence of IH | Single cardiovascular event | Within 1 year after treatment start | No |
| Secondary | Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Single cardiovascular event | Within 1 year after treatment start | No |
| Secondary | Time to first occurrence of MI | Single cardiovascular event | Within 1 year after treatment start | No |
| Secondary | Incidence density in study population of IS | Within 1 year after treatment start | No | |
| Secondary | Incidence density in study population of TIA | Within 1 year after treatment start | No | |
| Secondary | Incidence density in study population of IH | Within 1 year after treatment start | No | |
| Secondary | Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Within 1 year after treatment start | No | |
| Secondary | Incidence density in study population of MI | Within 1 year after treatment start | No | |
| Secondary | Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI | Within 1 year after treatment start | No |