Recruiting
Phase 4

Aspirin & Clopidogrel

Sponsor:

Todd C. Lee MD MPH FIDSA

Code:

NCT06650488

Conditions

Staphylococcus Aureus Endocarditis

Staphylococcus Aureus Septicemia

Staphylococcus Aureus Bloodstream Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clopidogrel

Aspirin

Study Details

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.

Conditions

Staphylococcus Aureus Endocarditis

Staphylococcus Aureus Septicemia

Staphylococcus Aureus Bloodstream Infection

Study ID

NCT06650488

Start date

Jan 15, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Change to clopidogrel

Patients will have their aspirin discontinued and start clopidogrel.

active comparator: Continue aspirin

Patients will continue their existing aspirin

Interventions

Clopidogrel

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

Aspirin

Patients will continue their existing aspirin.

Primary outcome measure

  • Desirability of Outcome Ranking (DOOR) [ Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119) ]

Central Contacts and Locations

Central contacts

Fatima Amari

5149341934fatima.amari@rimuhc.ca

Locations

NL and Labrador Health Services- Health Sciences Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, NL A1B 3V6

Contacts

Peter Daley, MD

Peter.Daley@easternhealth.ca

Principal Investigator:

Peter Daley, MD

NL and Labrador Health Services- St. Clare's Mercy Hospital

Recruiting

St. John's, Newfoundland and Labrador, Canada, NL A1C 5B8

Contacts

Peter Daley, MD

Peter.Daley@easternhealth.ca

Principal Investigator:

Peter Daley, MD

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

Recruiting

Montreal, Quebec, Canada, H4A3S1

Contacts

Fatima Amari

514-934-1934fatima.amari@rimuhc.ca

Principal Investigator:

Todd C Lee, MD MPH FIDSA

More Information

Sponsor

Todd C. Lee MD MPH FIDSA

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • S. aureus bactremia
  • S. aureus bloodstream infection
  • S. aureus endocarditis
  • aspirin
  • clopidogrel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Todd C. Lee MD MPH FIDSA on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.