NCT04753372

Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk

Effectiveness and Safety of Low Dose Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 645 (actual)
• Sponsor: Maatschap Cardiologie Zwolle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Registry to describe the impact in terms of effectiveness and safety of the combination treatment of rivaroxaban 2.5 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 2.5mg bid on top of ASA75-100mg OD (N=1000). Female and male patients with a diagnosis of CCS and/or symptomatic PAD will be enrolled in the (outpatient) clinic after the decision for treatment with rivaroxaban 2.5mg 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 g/dL (1.24 mmol/L) 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.

Conditions

• Coronary Artery Disease (CAD)
• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DRUG	Rivaroxaban 2.5 MG [Xarelto]	rivaroxaban 2.5mg bid on top of ASA for CAD and/or PAD

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2021-02-15
• Last updated: 2023-09-28

Locations

12 sites across 1 country: Netherlands