Clinical trial NCT06650488: Clopidogrel Vs. Aspirin in Patients with S. Aureus Bacteremia
Official title: Clopidogrel Vs. Aspirin in Patients with S. Aureus Bacteremia (Clopido-SNAP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Staphylococcus Aureus Endocarditis
Staphylococcus Aureus Septicemia
Staphylococcus Aureus Bloodstream Infection
Keywords: S. aureus bactremia
S. aureus bloodstream infection
S. aureus endocarditis
aspirin
clopidogrel
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 second RCT in people who do not currently have an indication for clopidogrel.


Eligibility 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

Primary outcomes:
measure: Desirability of Outcome Ranking (DOOR)
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Secondary outcomes:
measure: Clinical Failure
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Serious Adverse Event or Adverse Event Leading to Discontinuation
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: All cause mortality
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Infectious Complications
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Clinically relevant major bleeding
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Clinically relevant venous thromboembolic events
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Clinically relevant stroke
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Clinically relevant acute myocardial infarction
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
measure: Clinically relevant arterial thromboembolic event
timeFrame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Todd C Lee, MD MPH FIDSA
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of the McGill University Health Centre
name: Emily G McDonald, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gentry CA, Williams RJ 2nd, Whitman CM, Thind SK, Kliewer BS. Staphylococcus aureus bacteraemia treatment outcomes in patients receiving ticagrelor vs a propensity-matched cohort receiving clopidogrel. Int J Antimicrob Agents. 2023 Apr;61(4):106743. doi: 10.1016/j.ijantimicag.2023.106743. Epub 2023 Feb 2.
citation: Tong SYC, Mora J, Bowen AC, Cheng MP, Daneman N, Goodman AL, Heriot GS, Lee TC, Lewis RJ, Lye DC, Mahar RK, Marsh J, McGlothlin A, McQuilten Z, Morpeth SC, Paterson DL, Price DJ, Roberts JA, Robinson JO, van Hal SJ, Walls G, Webb SA, Whiteway L, Yahav D, Davis JS; Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clin Infect Dis. 2022 Nov 30;75(11):2027-2034. doi: 10.1093/cid/ciac476.
citation: Caffrey AR, Appaneal HJ, LaPlante KL, Lopes VV, Ulloa ER, Nizet V, Sakoulas G. Impact of Clopidogrel on Clinical Outcomes in Patients with Staphylococcus aureus Bacteremia: a National Retrospective Cohort Study. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0211721. doi: 10.1128/aac.02117-21. Epub 2022 Apr 13.