WILL lOWer Dose Aspirin be Better With Rivaroxaban in Patients With Chronic Coronary Syndromes?
CompletedPhase 4NCT04990791
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The trial is a pharmacodynamic study to determine the effect of a novel regimen of aspirin 20 mg BD plus rivaroxaban 2.5 mg BD on haemostasis, fibrin clot dynamics, inflammatory markers, platelet function and arachidonic acid metabolites when compared to standard regimens of aspirin 75 mg OD and aspirin 75 mg OD plus rivaroxaban 2.5 mg BD. In a randomised open-label three-period crossover design, patient participants receiving aspirin 75 mg OD for secondary prevention of IHD will be randomised 1:1 to receive one of two sequences of aspirin: aspirin 75 mg OD, then aspirin 20 mg BD plus rivaroxaban 2.5 mg BD, then aspirin 75 mg OD plus rivaroxaban 2.5 mg BD; or aspirin 75 mg OD, then aspirin 75 mg OD plus rivaroxaban 2.5 mg BD, then aspirin 20 mg BD plus rivaroxaban 2.5 mg BD. At the end of each 14(-2) day medication period, they will attend a study visit at which blood and urine samples will be obtained, and bleeding time measured, before and 2 hours after the last dose of IMP of the treatment period. The samples will be tested for fibrin clot dynamics; inflammatory markers and cytokines; prostanoids; and platelet function. Participants will be transitioned back to standard-of-care aspirin 75 mg OD at the end of the third treatment period and followed up by telephone call 14(-2) days later.
Study details
- Official title
- Characterisation of a Novel Regimen of Very Low-dose Aspirin Combined With Rivaroxaban in Patients With Chronic Coronary Syndromes: WILL lOWer Dose Aspirin be Better With Rivaroxaban in Patients With Chronic Coronary Syndromes?
- Conditions
- Coronary Syndrome
- Interventions
- Drug: Aspirin 75mg
- Drug: Aspirin 20mg
- Drug: Rivaroxaban 2.5 mg
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Start date
- 2021-08-26
- Primary completion
- 2023-08-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Male or female aged greater than 18 years 3. Existing diagnosis of a chronic coronary syndrome: (i) History of stable angina or (ii) History of an acute coronary syndrome event \>1 year ago or (iii) Previous evidence on imaging of either at least one stenosis \>50% in an epicardial coronary artery or a myocardial perfusion defect 4. Receiving single antiplatelet therapy with aspirin 75 mg once daily Exclusion Criteria: 1. Any history of haemorrhagic stroke or lacunar stroke 2. History of ischaemic stroke or transient ischaemic attack in the last year 3. Heart failure associated with NYHA class III or IV symptoms 4. Estimated glomerular filtration rate \<15 ml/min 5. Planned procedure for coronary revascularization 6. Any planned surgery or other procedure that may require suspension or discontinuation of antiplatelet therapy expected to occur within 3 months of randomisation 7. Prior intention by patient or physician to discontinue aspirin within the study period 8. Receiving doses of aspirin other than 75 mg once daily 9. Treatment or planned treatment with antiplatelet medication apart from aspirin (eg. clopidogrel, prasugrel, ticagrelor, dipyridamole, ticlopidine) 10. Current use of a loop, thiazide or potassium sparing diuretic (affects prostanoid assays) 11. Any acute coronary syndrome event, percutaneous coronary intervention or coronary artery bypass grafting within 1 year prior to randomisation 12. Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban \[including 2.5 mg BD\], apixaban, edoxaban) or parenteral anticoagulant (eg. unfractionated heparin, low molecular weight heparin, bivalirudin) 13. Current or planned use of a GPIIb/IIIa inhibitor (eg. abciximab, tirofiban) 14. Current or planned use of a fibrinolytic agent (eg. tissue plasminogen activator) 15. Requiring or likely to require treatment with a non-steroidal anti-inflammatory drug (NSAID), including COX2 inhibitors, and including regular or intermittent/as required use 16. Current or planned use of a strong CYP3A4 inhibitor (eg, ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin \[but not erythromycin or azithromycin\], nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, cobicistat or over 1 litre daily of grapefruit juice), strong inducer (e.g. rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital), a …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04990791