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Recruiting NCT06650488

Clopidogrel vs. Aspirin for Cardiovascular Risk Reduction in Patients With S. Aureus Bacteremia

Phase IV Interventional Staphylococcus Aureus Endocarditis Staphylococcus Aureus Septicemia Staphylococcus Aureus Bloodstream Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clopidogrel, Aspirin.
Who it may be relevant to
Registry conditions: Staphylococcus Aureus Endocarditis, Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bloodstream Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Clopidogrel
    Patients will change from aspirin to clopidogrel (without loading dose)
  • Drug Aspirin
    Patients will continue their existing aspirin.

Primary outcome measures

  • Desirability of Outcome Ranking (DOOR) [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
Secondary outcome measures (9)
  • Clinical Failure [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Serious Adverse Event or Adverse Event Leading to Discontinuation [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • All cause mortality [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Infectious Complications [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Clinically relevant major bleeding [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Clinically relevant venous thromboembolic events [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Clinically relevant stroke [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Clinically relevant acute myocardial infarction [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]
  • Clinically relevant arterial thromboembolic event [Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) — Montreal

Publications

  • 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. PMID 36736927
  • 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: PMID 35717634
  • 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. PMID 35416712

Identifiers

NCT: NCT06650488 · 2025-10899 · 500048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗