NCT06650488

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
45mo left

Started Jan 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

October 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 20, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

October 18, 2024

Last Update Submit

March 17, 2026

Conditions

Staphylococcus Aureus SepticemiaStaphylococcus Aureus Bloodstream InfectionStaphylococcus Aureus Endocarditis

Keywords

S. aureus bactremiaS. aureus bloodstream infectionS. aureus endocarditisaspirinclopidogrel

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

Secondary Outcomes (9)

  • 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)

  • Infectious Complications

    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)

  • +4 more secondary outcomes

Study Arms (2)

Change to clopidogrel

EXPERIMENTAL

Patients will have their aspirin discontinued and start clopidogrel.

Drug: Clopidogrel

Continue aspirin

ACTIVE COMPARATOR

Patients will continue their existing aspirin

Drug: Aspirin

Interventions

ClopidogrelDRUG

Patients will change from aspirin to clopidogrel (without loading dose)

Change to clopidogrel
AspirinDRUG

Patients will continue their existing aspirin.

Continue aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • Known receipt of clopidogrel, prasugrel, or ticagrelor within the last month
  • Allergy to clopidogrel
  • Concomitant receipt of oral Xa inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Montreal, Quebec, H4A3S1, Canada

RECRUITING

Related Publications (3)

  • 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: 36736927BACKGROUND

  • 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.

    PMID: 35717634BACKGROUND

  • 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: 35416712BACKGROUND

Related Links

MeSH Terms

Interventions

ClopidogrelAspirin

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Todd C Lee, MD MPH FIDSA

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

  • Emily G McDonald, MD MSc

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Petrella

CONTACT

5149341934lina.petrella@muhc.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine and Staff Scientist

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 21, 2024

Study Start

January 15, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 20, 2026

Record last verified: 2026-02

Locations

CA(1)