The Dutch rivaroxaban CCS registry is a study which investigates 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.

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.

This study is a national, multicentre (~15 sites), prospective, single-arm, observational study in patients treated with rivaroxaban 2.5mg bid on top of ASA80-100mg OD (N=1.000) for CAD and/or PAD. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy.

The first patient was enrolled at 21 December 2020.

Clinical investigators

Principal investigator:

Name: Rik Hermanides MD, PhD (intervention cardiologist)

Location: Isala, Zwolle

Clinical trial information Identifier: NCT04753372