Status:
COMPLETED
Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
Lead Sponsor:
Maatschap Cardiologie Zwolle
Collaborating Sponsors:
Diagram B.V.
Conditions:
Coronary Artery Disease (CAD)
Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
18+ years
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...
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 patien...
Eligibility Criteria
Inclusion
- 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 can only be enrolled in the study if the decision to treat with rivaroxaban plus ASA has been made by the treating physician in advance and independent of study inclusion, however within 4 weeks prior to study inclusion.
- Treatment according to local marketing authorization, with rivaroxaban 2.5 mg \[BID\] and 80mg ASA / 100mg Carbasalate calcium. Treatment of rivaroxaban started within 4 weeks prior or 4 weeks after study inclusion.
- Patients who are willing to participate in this study (signed informed consent).
Exclusion
- 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
Key Trial Info
Start Date :
December 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 13 2023
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT04753372
Start Date
December 21 2020
End Date
September 13 2023
Last Update
September 28 2023
Active Locations (12)
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1
Jeroen Bosch hospital
's-Hertogenbosch, Netherlands
2
OLVG
Amsterdam, Netherlands
3
Rijnstate hospital
Arnhem, Netherlands
4
Medisch Spectrum Twente
Enschede, Netherlands