Coronary Artery Disease (CAD)NCT04753372
Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
An observational study of Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD), run by Maatschap Cardiologie Zwolle at 12 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Peripheral Arterial Disease (PAD)
- What is being tested?
- Rivaroxaban 2.5 MG [Xarelto]
- How many people
- 645 participants
- Where
- 12 sitesNetherlands
- Study dates
- 21 Dec 2020to 13 Sep 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites
Jeroen Bosch hospital
's-Hertogenbosch
OLVG
Amsterdam
Rijnstate hospital
Arnhem
Medisch Spectrum Twente
Enschede
Zuyderland Medical Center
Heerlen
Isala Klinieken, location Meppel
Meppel
St. Antonius hospital
Nieuwegein
Haaglanden Medisch Centrum
The Hague
Hagaziekenhuis
The Hague
Elisabeth-Tweesteden hospital
Tilburg
VieCuri
Venlo
Isala hospital
Zwolle
About this study
Official title: Effectiveness and Safety of Low Dose Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
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.
Read the 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.
- Being tested
- Rivaroxaban 2.5 MG [Xarelto]
- Keywords
- Coronary Artery Disease (CAD), peripheral arterial disease (PAD), high ischemic risk
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 MG [Xarelto]Drug
Also called acetylsalicylic acid (ASA)
rivaroxaban 2.5mg bid on top of ASA for CAD and/or PAD
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Secondary Outcome Measures
The secondary efficacy and safety endpoint is the incidence of individual endpoints, that will be reported at 1 year:
- 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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start21 Dec 2020
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Maatschap Cardiologie Zwolle
- Sponsor type
- University, hospital or other
- Collaborators
- Diagram B.V.
- Responsible party
- Sponsor
- Investigators
- Rik Hermanides, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753372
- Sponsor's protocol ID
- Dutch Rivaroxaban CCS Registry
- Status last verified
- Sep 2023
- First submitted
- 22 Dec 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Low Dose Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
- ClinicalTrials.gov ID
- NCT04753372
- Acronym / sponsor ID
- Dutch Rivaroxaban CCS Registry
- Keywords
- Coronary Artery Disease (CAD), peripheral arterial disease (PAD), high ischemic risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Maatschap Cardiologie ZwolleUniversity, hospital or other
- Collaborators
- Diagram B.V.
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Adult (≥18 years) patient.
- Diagnosis of CAD and/or PAD and high risk of ischemic events.
- 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).
Key exclusion criteria (14 listed)
- Hypersensitivity/allergy and known contraindication to ASA/Carbasalate calcium or rivaroxaban
- Patients with recent major bleeding, active bleeding, or history with:
- Patients that have received any organ transplant or await any organ transplant
- Patient with anemia (Hb < 6.0 mmol/L)
- Patient with active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 MG [Xarelto]Also: acetylsalicylic acid (ASA)rivaroxaban 2.5mg bid on top of ASA for CAD and/or PAD | Drug | – |
Primary outcome
Primary Outcome Measures
Time frame: one year
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.
1 secondary outcome
Secondary Outcome Measures
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rik Hermanides, MD, PhD principal investigator
Isala
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD), run by Maatschap Cardiologie Zwolle at 12 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measures (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.