Antiplatelet Therapy for Coronary Heart Disease

(SWAP-9 Trial)

Overseen By Andrea Burton, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: Dual antiplatelet therapy

Must not be taking: Oral anticoagulants, Heparin

Disqualifiers: Stent thrombosis, Hemodynamic instability, 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 months

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be on dual antiplatelet therapy (DAPT) with low-dose aspirin and either prasugrel or ticagrelor. If you are already on these medications, you will not need to stop them. However, if you are taking any oral anticoagulants or certain other medications, you may not be eligible to participate.

What data supports the effectiveness of the drug Ticagrelor (Brilinta) for coronary heart disease?

Research shows that Ticagrelor, when used with low-dose aspirin, effectively reduces the rate of heart-related events in patients with acute coronary syndrome, a condition related to coronary heart disease. It works by preventing blood cells called platelets from clumping together, which can help prevent heart attacks. ^{1 2 3 4 5}

Is antiplatelet therapy safe for humans?

Antiplatelet drugs like ticagrelor, clopidogrel, and prasugrel are generally safe for humans but come with a risk of bleeding, which is a common warning for these types of medications. Ticagrelor has a specific warning that taking more than 100 mg of aspirin daily may reduce its effectiveness. ^{1 4 5 6 7}

How is the antiplatelet drug combination of Aspirin, Clopidogrel, Prasugrel, and Ticagrelor unique for coronary heart disease?

This combination of drugs is unique because it includes newer agents like Prasugrel and Ticagrelor, which provide more rapid and consistent platelet inhibition compared to older drugs like Clopidogrel, although they may increase bleeding risk in some patients. The treatment aims to tailor therapy to individual patient needs, considering their specific risks and responses to these medications. ^{1 3 8 9 10}

What is the purpose of this trial?

The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).

Eligibility Criteria

This trial is for individuals with coronary heart disease who have undergone a procedure to open their heart's arteries, known as PCI. Participants should be currently on dual antiplatelet therapy but cannot join if they have conditions that the study doesn't allow.

Inclusion Criteria

Provide written informed consent

I had a stent placed in my heart and take specific heart medications daily.

Exclusion Criteria

Prior history of stent thrombosis

I had a heart procedure within the last 30 days.

My blood pressure and heart rate are stable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dual antiplatelet therapy (DAPT) with either ABCD-GENE-guided or unguided de-escalation strategies following PCI

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurement of P2Y12 Reaction Units (PRU) at 30±5 days

4 weeks

Treatment Details

Interventions

• Aspirin
• Clopidogrel
• Prasugrel
• Ticagrelor

Trial Overview The SWAP-9 Study is testing whether it's better to choose post-PCI medication based on genetic information (ABCD-GENE guided) or not. It compares staying on standard drugs (aspirin and clopidogrel) versus switching to either Prasugrel or Ticagrelor alone.

Participant Groups

Group I: ABCD-GENE-guided de-escalation Experimental Treatment 1 Intervention

ABCD-GENE ≥10: prasugrel 10 mg qd or ticagrelor 90 mg od monotherapy. ABCD-GENE \<10: Aspirin 81 mg qd and clopidogrel 75 mg qd.

Group II: Unguided de-escalation Active Control 1 Intervention

Aspirin 81 mg qd and clopidogrel 75 mg qd.

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?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

Ticagrelor is a new type of P2Y(12) antagonist that works differently from traditional antiplatelet medications like clopidogrel and prasugrel, providing a potentially more effective option for treating acute coronary syndromes.

Clinical trials have shown that ticagrelor, when used with aspirin, has a favorable safety profile and can overcome some limitations associated with clopidogrel, making it a valuable addition to antiplatelet therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. Wijeyeratne, YD., Joshi, R., Heptinstall, S.[2022]

In a study of 249,907 patients with acute coronary syndrome (ACS), early initiation of dual anti-platelet therapy was associated with better outcomes, while triple therapy (thienopyridines + aspirin + glycoprotein IIb/IIIa receptor inhibitors) showed improved results compared to dual therapy in some cases.

Patients receiving glycoprotein IIb/IIIa receptor inhibitors had higher rates of major bleeding and mortality, indicating that while triple therapy can be beneficial, it also carries significant risks that need to be carefully managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes, health resource use, and cost in patients with early versus late dual or triple anti-platelet treatment for acute coronary syndrome. Friedman, H., Mollon, P., Lian, J., et al.[2018]

New antiplatelet agents like Prasugrel and Ticagrelor have been approved for treating acute coronary syndromes (ACS) in Europe, offering faster and more consistent platelet inhibition compared to traditional agents like aspirin and clopidogrel.

However, these newer medications also carry an increased risk of bleeding in certain patient groups, highlighting the need for personalized treatment plans that consider individual patient characteristics and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Platelet inhibitors in clinical practice]. Gebhard, C., Beer, J.[2018]

Ticagrelor (Brilinta) has been approved by the FDA as an oral antiplatelet medication to be used with low-dose aspirin for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

Ticagrelor will compete with existing medications like clopidogrel (Plavix) and prasugrel (Effient), especially as clopidogrel is expected to become available as a generic option soon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor (Brilinta)--better than clopidogrel (Plavix)? [2018]

Ticagrelor is an effective antiplatelet medication used in patients with acute coronary syndrome, helping to reduce the risk of heart attacks and other cardiovascular events.

Clinical studies have shown that ticagrelor provides a greater reduction in major adverse cardiovascular events compared to traditional treatments like clopidogrel, making it a preferred choice in acute settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. Fuller, R., Chavez, B.[2021]

Prasugrel (Effient) has been approved by the FDA as an oral antiplatelet medication to be used alongside aspirin for reducing thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

This new treatment option will compete with the existing antiplatelet drug clopidogrel (Plavix), potentially offering patients and healthcare providers more choices in managing cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prasugrel (Effient) vs. clopidogrel (Plavix). [2018]

Ticagrelor (Brilinta™) was approved by the FDA for treating acute coronary syndromes based on the PLATO trial, which involved 18,624 patients and compared its efficacy to clopidogrel over 6-12 months.

Despite its approval, there were significant concerns from FDA reviewers regarding its efficacy and safety, particularly related to bleeding risks and the potential reduction in effectiveness when used with high doses of aspirin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor FDA approval issues revisited. Serebruany, VL.[2018]

Dual antiplatelet therapy (DAPT), which includes aspirin and a P2Y12 inhibitor, remains the standard treatment for patients undergoing percutaneous coronary interventions (PCI) to reduce thrombotic events.

Recent randomized controlled trials have focused on finding less aggressive antithrombotic regimens that balance the risks of ischemic events and bleeding, leading to updates in clinical practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet therapy in percutaneous coronary intervention: latest evidence from randomized controlled trials. Galli, M., Angiolillo, DJ.[2023]

Antiplatelet therapy, particularly the combination of clopidogrel and aspirin, is the standard treatment for patients undergoing procedures like percutaneous coronary intervention and those with acute coronary syndromes to reduce cardiovascular events.

Despite the effectiveness of clopidogrel, there are significant limitations in its use, as some patients may still experience atherothrombotic events, highlighting the need for improved antiplatelet strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current antiplatelet therapies: benefits and limitations. Angiolillo, DJ., Guzman, LA., Bass, TA.[2018]

In the CURRENT-OASIS 7 trial involving 17,263 patients undergoing PCI, a 7-day double-dose regimen of clopidogrel significantly reduced the risk of major cardiovascular events and stent thrombosis compared to the standard dose.

There was no significant difference in efficacy or safety between high-dose and low-dose aspirin, indicating that either dosage can be used without impacting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Mehta, SR., Tanguay, JF., Eikelboom, JW., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical outcomes, health resource use, and cost in patients with early versus late dual or triple anti-platelet treatment for acute coronary syndrome. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Platelet inhibitors in clinical practice]. [2018]

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

Ticagrelor (Brilinta)--better than clopidogrel (Plavix)? [2018]

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

Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]

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

Prasugrel (Effient) vs. clopidogrel (Plavix). [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Ticagrelor FDA approval issues revisited. [2018]

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

Antiplatelet therapy in percutaneous coronary intervention: latest evidence from randomized controlled trials. [2023]

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

Current antiplatelet therapies: benefits and limitations. [2018]

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

Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. [2023]