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

NCT04753372 | Completed

• 1 other identifier: Dutch Rivaroxaban CCS Registry
• Study Type: observational
• Target: 645
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

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

Keywords

Coronary Artery Disease (CAD); peripheral arterial disease (PAD); high ischemic risk

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measures

  The primary efficacy endpoint is a composite of 1) Major Adverse Cardiovascular Events (MACE), which is a composite endpoint of cardiovascular mortality, myocardial infarction and stroke, 2) clinically driven coronary, peripheral or carotid revascularization, and 3) stent thrombosis, that will be reported at 1 year. The primary safety endpoint is major bleeding according to the International Society on Thrombosis and Haemostatsis (ISTH) criteria that will be reported at 1 year. It is a composite of 1) fatal bleeding, 2) symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome), 3) bleeding causing a fall in haemoglobin level of 2 g/dL (1.24 mmol/L) or more, or 4) leading to transfusion of two or more units of whole blood or red cells.

  one year

Secondary Outcomes (1)

• Secondary Outcome Measures

  one year

Interventions

Rivaroxaban 2.5 MG [Xarelto] DRUG

rivaroxaban 2.5mg bid on top of ASA for CAD and/or PAD

Also known as: acetylsalicylic acid (ASA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female and male patients with a diagnosis of CCS and/or symptomatic PAD will be enrolled in the (outpatient) clinic within 4 weeks after the decision for treatment with rivaroxaban 2x2.5mg plus ASA (75-100mg) has been made by the investigator (according to label (indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischemic events)) and who consent to participate in the study.

You may qualify if:

• Adult (≥18 years) patient.
• Diagnosis of CAD and/or PAD and high risk of ischemic events.
• Patients at high risk of ischaemic events include the following:
• CAD + PAD
• CAD + Recurrent MI (Previous MI followed by second MI)
• CAD + diabetes mellitus (all types)
• CAD + chronic kidney disease with eGFR 30-59 ml/min/1.73 m2 (CKD-EPI formula)
• CAD + heart failure (ejection fraction ≥30% - 50%) and New York Heart Association (NYHA) class I or II;)
• CAD + CHA2DS2VaSc ≥ 3 (for men) or ≥ 4 (for women)
• Patients who are willing to participate in this study (signed informed consent).

You may not qualify if:

• Hypersensitivity/allergy and known contraindication to ASA/Carbasalate calcium or rivaroxaban
• Patients with recent major bleeding, active bleeding, or history with:
• History of major clinical bleeding or known coagulopathy
• History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
• Known severe liver dysfunction
• Patients that have received any organ transplant or await any organ transplant
• Patient with anemia (Hb \< 6.0 mmol/L)
• Patient with active malignancy
• Patients with ejection fraction \< 30% and/or New York Heart Association (NYHA) class III or IV
• Patients with eGFR \< 30 ml/min/1.73m2 or undergoing dialysis
• Patients with liver failure accompanied with coagulopathy ( incl. Child-Pugh B and C)
• Patients with concomitant use of other anticoagulants or antiplatelet drugs
• Pregnant or lactating female
• Patients currently participating in another investigational drug or drug-coated device study

Sponsors & Collaborators

• Maatschap Cardiologie Zwolle: lead
• Diagram B.V.: collaborator

Study Sites (12)

Jeroen Bosch hospital

's-Hertogenbosch, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Rijnstate hospital

Arnhem, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Zuyderland Medical Center

Heerlen, Netherlands

Location

Isala Klinieken, location Meppel

Meppel, Netherlands

Location

St. Antonius hospital

Nieuwegein, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

Hagaziekenhuis

The Hague, Netherlands

Location

Elisabeth-Tweesteden hospital

Tilburg, Netherlands

Location

VieCuri

Venlo, Netherlands

Location

Isala hospital

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Rik Hermanides, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: February 15, 2021
• Study Start: December 21, 2020
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

NL (12)