This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking aspirin for secondary prevention of cardiovascular events. We will randomize patients to continue their aspirin or change clopidogrel which is also approved for secondary prevention.
Unlike aspirin, clopidogrel may have activity against S. aureus. We wish to determine if changing to clopidogrel will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.
This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).
If positive, this study will support a Phase 3 RCT in people who do not currently have an indication for clopidogrel.
None
Patient is taking aspirin for secondary prevention of cardiovascular disease (coronary, cerebrovascular, or peripheral vascular disease)
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 or lactation
Parallel
Clopidogrel
DrugPatients will change from aspirin to clopidogrel (without loading dose)
Aspirin
DrugPatients will continue their existing aspirin.
Desirability of Outcome Ranking (DOOR)
Desirability of Outcome Ranking (DOOR) - an ordinal outcome with 5 levels defined: Rank 1 - Alive without complication Rank 2 - Alive with 1 complication Rank 3 - Alive with 2 complications Rank 4 - Alive with 3 complications Rank 5 - Dead Complications include: 1. Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated. 2. Infectious Complications: Including new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures 3. Serious adverse drug event (Common Terminology Criteria class 4) due to study drug OR adverse drug event (classes 1-3) leading to discontinuation of the study drug
Clinical Failure
Defined as the absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment.
Serious Adverse Event or Adverse Event Leading to Discontinuation
Defined as a serious adverse drug event (Common Terminology Criteria for Adverse Events (CTCAE) class 4) presumed due to study drug OR adverse drug event (CTCAE classes 1-3) leading to discontinuation of the study drug
All cause mortality
Death from any cause
Infectious Complications
Defined as change in therapy for inadequate clinical response; new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures. New implies that the complication was not suspected at enrollment and is not a function of delay to diagnostic testing.
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Todd C. Lee MD MPH FIDSA
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
