Clopidogrel versus aspirin to lower cardiovascular and infection complications in people with Staphylococcus aureus bloodstream infection
Clopidogrel vs. Aspirin for Cardiovascular Risk Reduction in Patients With S. Aureus Bacteremia
This will try switching people with Staphylococcus aureus bloodstream infection who are already taking aspirin for heart protection to clopidogrel to see if it improves infection outcomes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06650488 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized trial enrolls patients with S. aureus bacteremia who are already on aspirin for secondary cardiovascular prevention and randomizes them to either continue aspirin or switch to clopidogrel. The trial compares clinical outcomes between the two antiplatelet strategies while following the SNAP platform protocols. Clopidogrel is of interest because laboratory and mechanistic data suggest it may have activity against S. aureus or modify host responses to infection. The study is a Phase 4 sub-study of the SNAP adaptive platform and, if findings are promising, could inform a larger Phase 3 trial in patients without a current indication for clopidogrel.
Who should consider this trial
Good fit: Adults with S. aureus bacteremia who are taking aspirin for secondary prevention of cardiovascular disease and who meet the SNAP platform eligibility, without recent P2Y12 inhibitor use, active bleeding, pregnancy, planned major surgery within 3 days, or concomitant oral Xa inhibitor therapy.
Not a fit: People who are not on aspirin, who have contraindications to clopidogrel (including allergy, recent P2Y12 use, active bleeding, concomitant oral Xa inhibitors, pregnancy, or imminent major surgery) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, switching to clopidogrel could reduce complications or improve recovery from S. aureus bloodstream infection in patients already on antiplatelet therapy.
How similar studies have performed: The approach is relatively novel for S. aureus bacteremia: preclinical and observational data hint at possible benefit from P2Y12 inhibition, but there is limited direct randomized trial evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria: Inclusion Criteria: * Patient is taking aspirin for secondary prevention of cardiovascular disease (coronary, cerebrovascular, or peripheral vascular disease) Exclusion Criteria: * Active bleeding (allowing up to 3 days from platform entry to randomize in the event anti-thrombotic therapy is resumed) * Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days * Pregnancy * Known receipt of clopidogrel, prasugrel, or ticagrelor within the last month * Allergy to clopidogrel * Concomitant receipt of oral Xa inhibitor
Where this trial is running
Montreal, Quebec
- McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Todd C Lee, MD MPH FIDSA — Research Institute of the McGill University Health Centre
- Study coordinator: Lina Petrella
- Email: lina.petrella@muhc.mcgill.ca
- Phone: 5149341934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.