Clopidogrel vs. Aspirin for Cardiovascular Risk Reduction in Patients With S. Aureus Bacteremia
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- Desirability of Outcome Ranking (DOOR)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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 or lactation
- •Known receipt of clopidogrel, prasugrel, or ticagrelor within the last month
- •Allergy to clopidogrel
- •Concomitant receipt of oral Xa inhibitor or dabigatran
Arms & Interventions
Continue aspirin
Patients will continue their existing aspirin
Intervention: Aspirin (Drug)
Change to clopidogrel
Patients will have their aspirin discontinued and start clopidogrel.
Intervention: Clopidogrel (Drug)
Outcomes
Primary Outcomes
Desirability of Outcome Ranking (DOOR)
Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
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
Secondary Outcomes
- Infectious Complications(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Clinical Failure(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Serious Adverse Event or Adverse Event Leading to Discontinuation(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- All cause mortality(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Clinically relevant major bleeding(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Clinically relevant venous thromboembolic events(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Clinically relevant stroke(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Clinically relevant acute myocardial infarction(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Clinically relevant arterial thromboembolic event(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
Investigators
Todd C. Lee MD MPH FIDSA
Associate Professor of Medicine and Staff Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre