Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726838
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-02-03
Brief Title:
The Belgian REAL BEREAL Registry
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Belgian Registry to Evaluate the Real Life Treatment With Inclisiran on Top of Standard of Care Lipid-lowering Therapy in Patients With Atherosclerotic Cardiovascular Disease
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BE REAL
Brief Summary:
This is an observational non-interventional study The visit schedule is according to the routine clinical practice Only data corresponding to study variables within the specified study period will be collected
The study will recruit patients into one single cohort Inclisiran in combination with other LLTs The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions
The study will recruit patients into one single cohort Inclisiran in combination with other LLTs The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions
Detailed Description:
The study aims to assess the effectiveness safety and adherence for Inclisiran in combination with lipid-lowering therapy LLT under conditions of routine clinical practice The Inclisiran cohort will include patients receiving Inclisiran therapy as per the approved label independently of background Standard of Care SoC therapy This study will include both primary data collection and secondary use of data
Prospective data collection Patients will be enrolled over a period of 6 months between 01-December-2022 and 31-May-2023 and will have a maximum follow-up of 39 months or 8 injection visits
Retrospective data collection Retrospective data will also be captured for patients with a first prescription between 01-May-2022 and study start and will be followed up for a maximum of 39 months to assess for study outcomes In this case baseline data and data of the first injection visits will be retrieved by the physician and captured in the Clinical Report Form CRF followed by prospective data collection during the rest of the follow-up period
Prospective data collection Patients will be enrolled over a period of 6 months between 01-December-2022 and 31-May-2023 and will have a maximum follow-up of 39 months or 8 injection visits
Retrospective data collection Retrospective data will also be captured for patients with a first prescription between 01-May-2022 and study start and will be followed up for a maximum of 39 months to assess for study outcomes In this case baseline data and data of the first injection visits will be retrieved by the physician and captured in the Clinical Report Form CRF followed by prospective data collection during the rest of the follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None