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

Trial Summary

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 data supports the effectiveness of the drugs Clopidogrel and Prasugrel for coronary artery disease?

Research shows that both Clopidogrel and Prasugrel are effective in preventing heart attacks and death in patients with acute coronary syndrome, a condition related to coronary artery disease. Prasugrel may work faster and more consistently than Clopidogrel, but it might also increase the risk of bleeding in some patients. ^{1 2 3 4 5}

Is antiplatelet therapy with Clopidogrel and Prasugrel safe for humans?

Both Clopidogrel and Prasugrel are generally safe for humans, but they can increase the risk of bleeding. Prasugrel may have a higher risk of bleeding compared to Clopidogrel, although it is more effective in preventing heart-related events. ^{6 7 8 9 10}

How does the drug combination of Clopidogrel and Prasugrel differ from other treatments for coronary artery disease?

The combination of Clopidogrel and Prasugrel is unique because Prasugrel offers a faster onset of action and more consistent platelet inhibition compared to Clopidogrel, making it particularly effective for patients with acute coronary syndrome and those undergoing coronary interventions. However, it also carries a higher risk of bleeding, especially in older patients or those with lower body weight. ^{11 12 13 14 15}

What is the purpose of this trial?

Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. 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 prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.

Eligibility Criteria

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

I had a heart procedure within the last 30 days.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral antiplatelet therapy for the management of acute coronary syndromes: defining the role of prasugrel. [2015]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clopidogrel, prasugrel, and ticagrelor for all-comers with ST-segment elevation myocardial infarction. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Comparative resource utilization and costs for patients with acute coronary syndrome managed with percutaneous coronary intervention and treated with clopidogrel or prasugrel. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Prasugrel versus clopidogrel in patients with ST-segment elevation myocardial infarction according to timing of percutaneous coronary intervention: a TRITON-TIMI 38 subgroup analysis (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38). [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Platelet inhibition with prasugrel]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Prasugrel: a novel antiplatelet agent. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Switching From Clopidogrel to Prasugrel in Patients Undergoing Percutaneous Coronary Intervention: A Study-level Meta-analysis From 15 Studies. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Prasugrel: a novel platelet ADP P2Y12 receptor antagonist. A review on its mechanism of action and clinical development. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical profile of prasugrel, a novel thienopyridine. [2015]

12. Germany pubmed.ncbi.nlm.nih.gov

[Prasugrel]. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Antiplatelet therapy for secondary prevention of coronary artery disease. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Republished: Antiplatelet therapy for secondary prevention of coronary artery disease. [2015]

15. England pubmed.ncbi.nlm.nih.gov

Prasugrel: newest antiplatelet agent and its emerging role in management of acute coronary syndrome and percutaneous coronary intervention. [2018]