Antiplatelet Therapy Strategies for Coronary Artery Disease

(SWAP-8 Trial)

Overseen By Andrea Burton, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: Low-dose aspirin, Prasugrel, Ticagrelor

Must not be taking: Oral anticoagulants, Heparin

Disqualifiers: Stent thrombosis, Cerebrovascular event, 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: 2

Duration: 4 weeks

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce bleeding risks for individuals with coronary artery disease who currently take two types of blood thinners (antiplatelet drugs) after certain heart procedures. It compares two strategies: lowering the dose of prasugrel or switching to clopidogrel, to determine if they are equally effective and safer. Individuals who underwent a heart procedure called PCI (a method to open blocked heart arteries) more than 30 or 90 days ago and take these medications might be suitable for this study. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it seems you need to be on a specific dual antiplatelet therapy (DAPT) with low-dose aspirin and either prasugrel or ticagrelor to participate. If you are on other medications, especially oral anticoagulants, you may not be eligible.

What is the safety track record for these treatments?

Research shows that both prasugrel and clopidogrel are well-researched medications used to prevent blood clots in people with heart conditions. Studies have found that prasugrel reduces heart attacks more effectively than clopidogrel. However, prasugrel carries a higher risk of causing bleeding. For instance, one study found that 7.4% of patients taking prasugrel had heart attacks, compared to 9.7% of those taking clopidogrel, but those on prasugrel experienced more bleeding.

Clopidogrel is generally safer regarding bleeding but is less effective than prasugrel in preventing heart problems. Both drugs have FDA approval, indicating they have been tested for safety and effectiveness for other uses. Overall, while both treatments are generally considered safe, prasugrel may pose a higher risk of bleeding compared to clopidogrel. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores two innovative strategies for adjusting antiplatelet therapy in coronary artery disease. Unlike the typical approach of maintaining a constant dosage, the "DAPT de-escalation by dose-reduction" strategy gradually reduces the dosage to potentially minimize side effects while maintaining efficacy. On the other hand, the "DAPT de-escalation by switch" strategy involves switching between medications, which might offer a better balance between effectiveness and safety. These approaches could lead to more personalized and patient-friendly treatment plans, potentially improving outcomes for those with coronary artery disease.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that lowering the dose of dual antiplatelet therapy (DAPT) can reduce bleeding risk while still protecting against heart attacks. In this trial, one arm involves de-escalating DAPT by reducing the dose of prasugrel, which some studies have found results in fewer bleeding incidents while maintaining good protection against blood clots. Another arm involves switching to clopidogrel, which has also effectively balanced safety and clot prevention. Both methods in this trial aim to reduce bleeding while still providing strong protection for the heart after a heart event. These strategies have proven very effective in reducing bleeding and maintaining heart health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients with coronary artery disease who've had an acute event or a procedure to open their arteries. They must be on dual antiplatelet therapy but can't join if they have conditions that the study excludes, which aren't specified here.

Inclusion Criteria

Provide written informed consent.

I had a heart procedure, take specific heart medications, and it's been over 30 or 90 days since.

Exclusion Criteria

Prior history of stent thrombosis

Prior cerebrovascular event

Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo DAPT de-escalation by either dose reduction or switching, following PCI

4 weeks

1 visit (in-person) for PCI, followed by regular monitoring

Follow-up

Participants are monitored for platelet reactivity and safety after treatment

4 weeks

1 visit (in-person) for VerifyNow testing

What Are the Treatments Tested in This Trial?

Interventions

• Clopidogrel
• Prasugrel

Trial Overview The study tests two ways to reduce bleeding risk in heart patients while protecting against clots: one group will take a lower dose of Prasugrel (5 mg), and another will switch to standard-dose Clopidogrel (75 mg). It's a head-to-head test to see if both methods are equally effective.

How Is the Trial Designed?

Group I: DAPT de-escalation by dose-reduction Experimental Treatment 1 Intervention

Group II: DAPT de-escalation by switch Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Aspirin is the primary antiplatelet therapy for secondary prevention of coronary artery disease (CAD), often used in combination with clopidogrel for patients undergoing procedures like percutaneous coronary intervention.

In patients with acute coronary syndrome, newer agents like prasugrel and ticagrelor provide better outcomes by reducing ischemic events, but they also carry a higher risk of bleeding compared to clopidogrel, with prasugrel being particularly effective for those with ST elevation myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet therapy for secondary prevention of coronary artery disease. Pilgrim, T., Windecker, S.[2022]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013263

Antiplatelet De-Escalation Strategies in Patients ... Antiplatelet de-escalation is a strategy consisting of reducing the potency of antiplatelet therapy after a short period of intense antiplatelet treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06821191

Comparison of Dual Antiplatelet Therapy De-escalation by ... The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824009130

Real-World Implementation of a Genotype-Guided P2Y12 ... The implementation of a CYP2C19 genotype–guided P2Y 12 inhibitor de-escalation strategy in a real-world ACS population resulted in lower bleeding rates.

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2813198

Dual Antiplatelet Therapy De-Escalation in Stabilized ... The findings suggest that the de-escalation strategy is a safe and reasonable option following myocardial infarction in patients with high ischemic risk.

5. jacc.org jacc.org/doi/10.1016/j.jacc.2021.06.012

De-Escalation of Dual Antiplatelet Therapy in Patients With ... Of the 5 DAPT strategies, DAPT de-escalation was ranked as the most effective for reducing the primary efficacy outcome and reducing bleeding events (P-scores: ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2773746/

Comparison of prasugrel and clopidogrel in patients with ... The enhanced platelet inhibition with prasugrel led to a reduction in major adverse cardiovascular events in patients with moderate to high risk ACS scheduled ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa0706482

Prasugrel versus Clopidogrel in Patients with Acute ... We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.046786

Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in ... Prasugrel and ticagrelor reduced ischemic events and increased bleeding in comparison with clopidogrel. A significant mortality reduction was observed with ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625015624

Clopidogrel versus aspirin for secondary prevention of ... We analysed patient-level data from all available randomised trials comparing clopidogrel and aspirin monotherapy for secondary prevention in ...

10. jacc.org jacc.org/doi/10.1016/j.jcin.2015.03.023

Safety of Prasugrel Loading Doses in Patients Pre ... At 30 days, the primary safety endpoint was observed in 1.9% of those receiving clopidogrel and a subsequent prasugrel loading dose and 3.4% of ...