Ticagrelor vs Clopidogrel for Coronary Artery Disease

(SWAP-AC-2 Trial)

Overseen By Francesco Franchi

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: P2Y12 inhibitors, NOACs

Must not be taking: CYP 3A4 inhibitors, inducers

Disqualifiers: Active bleeding, Stroke, Cancer, 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: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two heart medications, clopidogrel (Plavix) and ticagrelor, to determine which is more effective for individuals with coronary artery disease who have undergone a procedure to open clogged arteries. It focuses on those who may not respond well to clopidogrel, a common medication in these cases. The trial aims to assess how these drugs affect blood platelets, which aid in clotting, in individuals also taking blood thinners. Candidates may be suitable if they have recently undergone an artery-clearing procedure and are on blood thinners like apixaban or rivaroxaban. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they benefit a broader range of patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain strong medications that affect liver enzymes, like some antifungal or HIV drugs.

What is the safety track record for these treatments?

Research shows that ticagrelor can lower the risk of heart problems, such as heart attacks and strokes. However, it may increase bleeding risk, especially when combined with aspirin. Monitoring for any signs of bleeding while using ticagrelor is crucial.

Clopidogrel has been widely used, and most people tolerate it well. Serious side effects are rare, but it can cause bleeding, like any medication.

The FDA has approved both medications for treating coronary artery disease, indicating their safety. While both can be effective, informing your doctor about any side effects is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ticagrelor because it offers a potentially more effective alternative to clopidogrel, which is a common treatment for coronary artery disease. Unlike clopidogrel, ticagrelor works by reversibly binding to platelet receptors, which may lead to more consistent platelet inhibition. This unique mechanism could reduce the risk of heart attacks or strokes more effectively in certain patients. Furthermore, ticagrelor's twice-daily dosing could help maintain a more stable level of the drug in the body, potentially improving outcomes for those with higher ABCD-GENE scores.

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

This trial will compare Ticagrelor and Clopidogrel for patients with coronary artery disease. Research has shown that ticagrelor can benefit people with this condition. In one study, patients who took ticagrelor after a heart attack experienced fewer heart problems compared to those who did not. Another study found that ticagrelor, when combined with aspirin, reduced the risk of future heart issues. Additionally, research demonstrated that ticagrelor was more effective than clopidogrel in reducing heart problems for patients who underwent complex heart procedures. Overall, ticagrelor appears to be a strong option for lowering heart-related risks in these patients. Participants in this trial will be randomized to receive either ticagrelor or clopidogrel to assess their effectiveness in this context. ^{1 3 6 7 8}

Who Is on the Research Team?

Dominick J Angiolillo, MD, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Adults over 18 who've had successful PCI and are on dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) and an oral anticoagulant for any reason. They must not be in other drug studies, have major bleeding issues, severe liver disease, recent strokes, life-threatening non-cardiovascular diseases, end-stage renal disease on dialysis, or allergies to the study drugs.

Inclusion Criteria

I am currently taking a specific blood thinner (apixaban, dabigatran, edoxaban, or rivaroxaban).

Willing and able to provide written informed consent

I have had a successful heart stent placement and am on blood thinning medication.

Exclusion Criteria

I have severe liver problems or a liver disease that affects my blood clotting.

Your hemoglobin level is less than 9 mg/dL.

I have no active bleeding or history of major bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either ticagrelor or clopidogrel based on their ABCD-GENE score, with treatment maintained for 30 days

4 weeks

1 visit (in-person) for randomization, weekly follow-ups (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with platelet reactivity measured as PRU

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clopidogrel
• Ticagrelor 60mg

Trial Overview The trial is testing how well two blood-thinning medications—Ticagrelor and Clopidogrel—work in patients with coronary artery disease who also need oral anticoagulation after PCI. It aims to see if one is better at preventing platelets from clumping together using a scoring system called ABCD-GENE.

How Is the Trial Designed?

Group I: ABCD-GENE >10 - Ticagrelor Experimental Treatment 1 Intervention

Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.

Group II: ABCD-GENE >10 - Clopidogrel Active Control 1 Intervention

Patients with an ABCD-GENE\>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.

Group III: ABCD-GENE <10 - Clopidogrel Active Control 1 Intervention

Patients with an ABCD-GENE\<10 will be treated with clopidogrel (75 mg/qd) for 30 days.

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

Approved in European Union as Plavix for:

• Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
• Acute coronary syndrome

Approved in United States as Plavix for:

• Reduction of myocardial infarction and stroke in patients with acute coronary syndrome
• Reduction of myocardial infarction and stroke in patients with recent myocardial infarction, recent stroke, or established peripheral arterial disease

Approved in Canada as Plavix for:

• Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
• Acute coronary syndrome

Approved in Japan as Plavix for:

• Prevention of recurrence of ischemic cerebrovascular disorder
• Prevention of recurrence of myocardial infarction

Approved in China as Plavix for:

• Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
• Acute coronary syndrome

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031606

Review of the Ticagrelor Trials Evidence Base In the CHANCE trial, the 90‐day outcome of ischemic or hemorrhagic stroke in Chinese patients was reduced (8.2% versus 11.7%; HR, 0.68 [95% CI, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27480967/

Long-Term Therapy in Patients with Coronary Artery Disease The aim of our paper is to review the long-term effect of therapy with ticagrelor on the basis of recent evidence based data. Methods: We performed an online ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1908077

Ticagrelor in Patients with Stable Coronary Disease and ... Ticagrelor plus aspirin had a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus ...

4. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2015/03/11/19/41/PEGASUS-TIMI-54

PEGASUS-TIMI 54 The PEGASUS-TIMI 54 trial showed that among aspirin-treated individuals with prior MI, ticagrelor reduced cardiovascular events.

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.768190/full

Ticagrelor vs. Clopidogrel After Complex Percutaneous ... The primary efficacy outcome after complex PCI occurred in 8.6% of patients in the ticagrelor group and 11.2% in the clopidogrel group. Compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6749839/

Efficacy and safety with ticagrelor in patients with prior ... In such a population, ticagrelor reduced the risk of the primary endpoint of CV death, MI, or stroke by 20%, coronary heart death by 28%, CV mortality by 29%, ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2024.03.377

Limb Outcomes With Ticagrelor Plus Aspirin in Patients ... Ticagrelor reduced major adverse cardiovascular events (MACE) and increased bleeding in patients with type 2 diabetes mellitus (T2DM) and coronary artery ...

8. brilintahcp.com brilintahcp.com/cad.html

Coronary Artery Disease (CAD) | BRILINTA | For HCPs BRILINTA® (ticagrelor) is indicated for treatment in patients with high-risk coronary artery disease (CAD) without history of MI or stroke.