Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753372
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-12-22
Brief Title:
Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
Sponsor:
Maatschap Cardiologie Zwolle
Organization:
Maatschap Cardiologie Zwolle
Study Overview
Official Title:
Effectiveness and Safety of Low Dose Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
Status:
COMPLETED
Status Verified Date:
2023-09
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:
None
Brief Summary:
Registry to describe the impact in terms of effectiveness and safety of the combination treatment of rivaroxaban 25 mg twice daily with aspirin on clinical outcomes and practices in a real-life Dutch patient population that are at high risk of ischemic events
Detailed Description:
This study is a national multicentre 15 sites prospective single-arm observational study in patients treated with rivaroxaban 25mg bid on top of ASA75-100mg OD N1000 Female and male patients with a diagnosis of CCS andor symptomatic PAD will be enrolled in the outpatient clinic after the decision for treatment with rivaroxaban 25mg bid co-administered with acetylsalicylic acid has been made by the treating physician
The primary effectiveness endpoint is a composite of
Major Adverse Cardiac Events MACE including stroke cardiovascular mortality and myocardial infarction
Clinically driven coronary peripheral or carotid revascularization
Stent thrombosis at one year
The primary safety endpoint is Major Bleeding at one year These major bleeding complications are analysed according to the International Society on Thrombosis and Haemostasis ISTH criteria as a composite of fatal bleeding symptomatic bleeding into a critical organ such as intracranial intraspinal intraocular retroperitoneal intra-articular or pericardial or intramuscular with compartment syndrome bleeding causing a fall in haemoglobin level of 2 gdL 124 mmolL or more or leading to transfusion of two or more units of whole blood or red cells
The secondary endpoints will be
Occurrence and date of stroke
Occurrence and date of myocardial infarction
Occurrence and date of cardiovascular death
Occurrence and date of coronary revascularization procedures PCI CABG
Occurrence and date of peripheral revascularization procedures
Occurrence and date of carotid revascularization procedures
Occurrence and date of minor bleeding complications according to ISTH
In addition all bleeding events including minor bleedings according to ISTH definitions will be reported
The primary effectiveness endpoint is a composite of
Major Adverse Cardiac Events MACE including stroke cardiovascular mortality and myocardial infarction
Clinically driven coronary peripheral or carotid revascularization
Stent thrombosis at one year
The primary safety endpoint is Major Bleeding at one year These major bleeding complications are analysed according to the International Society on Thrombosis and Haemostasis ISTH criteria as a composite of fatal bleeding symptomatic bleeding into a critical organ such as intracranial intraspinal intraocular retroperitoneal intra-articular or pericardial or intramuscular with compartment syndrome bleeding causing a fall in haemoglobin level of 2 gdL 124 mmolL or more or leading to transfusion of two or more units of whole blood or red cells
The secondary endpoints will be
Occurrence and date of stroke
Occurrence and date of myocardial infarction
Occurrence and date of cardiovascular death
Occurrence and date of coronary revascularization procedures PCI CABG
Occurrence and date of peripheral revascularization procedures
Occurrence and date of carotid revascularization procedures
Occurrence and date of minor bleeding complications according to ISTH
In addition all bleeding events including minor bleedings according to ISTH definitions will be reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None