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

81 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. However, you cannot participate if you are on certain strong medications that affect liver enzymes, like some antifungal or HIV drugs.

What data supports the effectiveness of the drug Ticagrelor 60mg compared to Clopidogrel for treating coronary artery disease?

Research shows that Ticagrelor provides more rapid and consistent platelet inhibition than Clopidogrel, which is important for preventing blood clots in heart conditions. Additionally, studies have explored the effectiveness of Ticagrelor in patients with heart attacks undergoing procedures to open blocked arteries, suggesting potential benefits over Clopidogrel. ^{1 2 3 4 5}

Is ticagrelor safe compared to clopidogrel for coronary artery disease?

Research suggests that ticagrelor may have a higher risk of causing bleeding compared to clopidogrel, especially in older patients with heart conditions who have undergone procedures to open blocked arteries. ^{2 3 4 6 7}

How does the drug Ticagrelor differ from Clopidogrel for coronary artery disease?

Ticagrelor is known for providing more rapid and consistent platelet inhibition compared to Clopidogrel, which can be beneficial in reducing major adverse coronary events, although it may increase the risk of bleeding and shortness of breath. This makes Ticagrelor a preferred option in certain guidelines for acute coronary syndrome, but its benefits in stable coronary artery disease are still being evaluated. ^{3 5 6 8 9}

What is the purpose of this trial?

Clopidogrel is the P2Y12 inhibitor of choice in PCI patients requiring OAC. However, concerns have been raised based on the notion that a considerable number of patients may have inadequate response to clopidogrel. Although practice recommendations indicate that the use of potent P2Y12 inhibitors (i.e., ticagrelor) may be considered in patients at increased thrombotic risk, they do not recommend routine testing to identify patients with poor response to clopidogrel. The aim of this study is to assess the pharmacodynamic effects of different P2Y12 inhibiting therapy (clopidogrel vs ticagrelor) in patients at high risk for high platelet reactivity identified according to the ABCD-GENE score in PCI treated patients also requiring OAC. Up to a total of up to 63 patients are planned to be prospectively enrolled in this investigation which will entail a series of comprehensive pharmacodynamic assessments to reach the study aim.

Research Team

Dominick J Angiolillo, MD, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

Effectiveness of dual antiplatelet de-escalation therapy on the prognosis of patients with ST segment elevation myocardial infarction undergoing percutaneous coronary intervention. [2023]

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

Ticagrelor versus clopidogrel in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention. [2022]

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

Comparison Between Ticagrelor and Clopidogrel in Elderly Patients With an Acute Coronary Syndrome: Insights From the SWEDEHEART Registry. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of P2Y12 inhibitors in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: a nationwide registry-based study. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Randomised trial to compare a protective effect of Clopidogrel Versus TIcagrelor on coronary Microvascular injury in ST-segment Elevation myocardial infarction (CV-TIME trial). [2018]

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

Ticagrelor or Clopidogrel After an Acute Coronary Syndrome in the Elderly: A Propensity Score Matching Analysis from 16,653 Patients Treated with PCI Included in Two Large Multinational Registries. [2022]

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

Choosing between ticagrelor and clopidogrel following percutaneous coronary intervention: A systematic review and Meta-Analysis (2007-2017). [2022]

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

Association of Ticagrelor vs Clopidogrel With Major Adverse Coronary Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. [2021]

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

Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease. [2023]