Clopidogrel vs. Aspirin for Staph Bloodstream Infection

(Clopido-SNAP Trial)

Overseen By Lina Petrella

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Todd C. Lee MD MPH FIDSA

Must be taking: Aspirin

Must not be taking: Clopidogrel, Prasugrel, Ticagrelor, Xa inhibitors

Disqualifiers: Active bleeding, Major surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether switching from aspirin to clopidogrel can improve recovery from a Staph bloodstream infection in patients who take aspirin to prevent heart problems. Clopidogrel (also known as Plavix) is already used for heart issues and might also help fight the infection. Participants will either continue taking aspirin or switch to clopidogrel. The trial seeks individuals who regularly take aspirin to prevent heart attacks, strokes, or other heart-related issues. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

If you are taking aspirin for heart-related issues, you may be asked to switch to clopidogrel for the trial. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.

What is the safety track record for these treatments?

Research has shown that clopidogrel, a drug typically used to prevent heart attacks and strokes, might also benefit patients with Staphylococcus aureus bloodstream infections. One study found that clopidogrel reduced in-hospital deaths by 89% and deaths within 30 days by 57% for these patients. This suggests clopidogrel could be useful not only for heart issues but also for treating these serious infections.

Regarding safety, the FDA has already approved clopidogrel for heart conditions, and its safety is well-documented. While some studies noted differences in infection-related deaths compared to other similar drugs, clopidogrel is generally well-tolerated by many patients. For those considering joining a trial, this existing information can offer reassurance about its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about clopidogrel for treating staph bloodstream infections because it offers a different approach compared to the standard use of aspirin. While aspirin works by inhibiting platelet aggregation in a general sense, clopidogrel specifically targets the P2Y12 receptor on platelets, which might provide more precise control of platelet activity in the context of infections. This precise mechanism could potentially reduce complications associated with staph bloodstream infections more effectively. Additionally, using clopidogrel could lead to fewer side effects related to gastrointestinal issues that are sometimes seen with aspirin use.

What evidence suggests that this trial's treatments could be effective for S. aureus bacteremia?

Research has shown that clopidogrel can significantly reduce deaths in patients with Staphylococcus aureus (S. aureus) bloodstream infections. Specifically, using clopidogrel when the infection occurs lowered the in-hospital death rate by 89% and the 30-day death rate by 57%. This suggests clopidogrel might improve recovery for people with these infections. In this trial, one group of participants will switch from aspirin to clopidogrel to assess its impact on recovery from S. aureus infections. While aspirin is already used to prevent heart problems, it lacks the proven benefits for S. aureus infections that clopidogrel offers. Another group in this trial will continue their existing aspirin regimen to compare outcomes. The trial investigates whether switching from aspirin to clopidogrel can significantly benefit those needing it for heart health and facing this type of infection. ^{2 3 5 6 7}

Who Is on the Research Team?

Todd C Lee, MD MPH

Principal Investigator

Research Institute of the McGill University Health Centre

Emily G McDonald, MD MSc

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for patients with a Staphylococcus aureus blood infection who are already using aspirin to prevent heart problems. It's part of a larger study and may lead to another trial if results are positive.

Inclusion Criteria

I am taking aspirin to prevent further heart or blood vessel disease.

Exclusion Criteria

Allergy to clopidogrel

I am currently taking an oral Xa inhibitor medication.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continue aspirin or switch to clopidogrel for secondary prevention of cardiovascular events

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical failure, adverse events, and mortality

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Clopidogrel

Trial Overview The study compares the effects of continuing aspirin versus switching to clopidogrel, which might help fight the bacterial infection, in improving patient outcomes.

How Is the Trial Designed?

Group I: Change to clopidogrel Experimental Treatment 1 Intervention

Patients will have their aspirin discontinued and start clopidogrel.

Group II: Continue aspirin Active Control 1 Intervention

Patients will continue their existing aspirin

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Todd C. Lee MD MPH FIDSA

Lead Sponsor

Trials

3

Recruited

660+

Published Research Related to This Trial

In a study of 70 patients who had recently experienced an ischemic stroke, combining clopidogrel with aspirin (C+ASA) resulted in significantly greater inhibition of platelet activity compared to aspirin alone (ASA), indicating enhanced antiplatelet protection.

The C+ASA treatment led to notable reductions in various platelet activation markers and microparticle formation, with no serious adverse events reported, suggesting it is a safe and effective option for improving platelet inhibition in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of clopidogrel and aspirin in combination versus aspirin alone on platelet activation and major receptor expression in patients after recent ischemic stroke: for the Plavix Use for Treatment of Stroke (PLUTO-Stroke) trial. Serebruany, VL., Malinin, AI., Ziai, W., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9211425/

Impact of Clopidogrel on Clinical Outcomes in Patients with ... Clopidogrel use at the time of infection reduced in-hospital mortality by 89% and 30-day mortality by 57% among a cohort of patients with S. aureus bacteremia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0924857923000316

Staphylococcus aureus bacteraemia treatment outcomes in ... Several clinical studies have shown that treatment with ticagrelor was associated with decreased risk of S. aureus bacteraemia, sepsis and pneumonia in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06650488

Clopidogrel Vs. Aspirin in Patients with S. Aureus Bacteremia 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 ...

4. journals.plos.org journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1010240

Antiplatelet therapy for Staphylococcus aureus bacteremia Some clinical data suggest that patients treated with ticagrelor are less likely to have poor outcomes due to S. aureus infection.

5. digitalcommons.uri.edu digitalcommons.uri.edu/cgi/viewcontent.cgi?article=2738&context=php_facpubs

Impact of Clopidogrel on Clinical Outcomes in Patients with ... Clopidogrel use at the time of infection reduced in-hospital mortality by 89% and 30-day mortality by 57% among a cohort of patients with S. aureus bacteremia.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35416712/

Impact of Clopidogrel on Clinical Outcomes in Patients with ... Clopidogrel use at the time of infection reduced in-hospital mortality by 89% and 30-day mortality by 57% among a cohort of patients with S. aureus bacteremia.

7. journals.asm.org journals.asm.org/doi/10.1128/aac.00365-22

Antiplatelet Therapy in Staphylococcus aureus Bacteremia Patients receiving the platelet ADP P2Y12 (P2Y12) inhibitor ticagrelor had a lower risk of infection-related death than those receiving clopidogrel.