Clopidogrel vs. Aspirin as Anti-thrombotic Therapy in Patients With S. Aureus Bacteremia (Clopido-SNAP 2)

Todd C. Lee MD MPH FIDSA

Status and phase: Enrolling; Phase 4

Conditions: Staphylococcus Aureus Septicemia; Staphylococcus Aureus Endocarditis; Staphylococcus Aureus Bloodstream Infection

Treatments: Drug: Clopidogrel; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT06650488

2025-10899

500048 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Change to clopidogrel

Experimental group

Description:

Patients will have their aspirin discontinued and start clopidogrel.

Treatment:

Drug: Clopidogrel

Continue aspirin

Active Comparator group

Description:

Patients will continue their existing aspirin

Treatment:

Drug: Aspirin