50 Participants Needed

Ticagrelor vs. Clopidogrel for Coronary Artery Disease

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AB
Overseen ByAndrea Burton, MPH, CPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Florida
Must be taking: Aspirin, Clopidogrel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be on low-dose aspirin and clopidogrel for at least 24 hours after the procedure. If you are currently taking prasugrel, ticagrelor, or certain other medications, you may need to stop those before joining the trial.

What data supports the effectiveness of the drug Ticagrelor for coronary artery disease?

Research shows that Ticagrelor is more effective than Clopidogrel in reducing heart attacks, strokes, or cardiovascular deaths in patients with acute coronary syndromes. It also has a faster onset of action and provides greater inhibition of platelet aggregation, which helps prevent blood clots.12345

Is Ticagrelor safe for humans?

Ticagrelor is generally well tolerated but can cause some side effects like shortness of breath and heart rhythm issues. It has a warning for bleeding risks, which is common for drugs that prevent blood clots. Most people handle it well, but it's important to discuss any concerns with a doctor.12456

What makes the drug Ticagrelor unique for treating coronary artery disease?

Ticagrelor is unique because it is a reversible platelet inhibitor that works faster and provides stronger platelet inhibition than clopidogrel, which can lead to better outcomes in reducing heart attacks, strokes, or cardiovascular deaths in patients with acute coronary syndromes.12457

What is the purpose of this trial?

The proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better pharmacodynamic effects (i.e., lower platelet reactivity and high platelet reactivity rates) compared with clopidogrel in stable coronary artery disease patients undergoing percutaneous coronary intervention with a high ABCD-GENE score.

Research Team

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Francesco Franchi, MD

Principal Investigator

Univesrsity of Florida

Eligibility Criteria

This trial is for stable coronary artery disease patients undergoing elective heart procedure (PCI), aged 18 or older, with no recent heart attack and on low-dose aspirin plus clopidogrel. They must have a high genetic risk score (ABCD-GENE ≥10) and normal or slightly elevated troponin levels. Excluded are those with allergies to the drugs being tested, certain other medications, severe liver disease, low blood counts, potential bradycardia without a pacemaker, active bleeding issues, or women not using contraception.

Inclusion Criteria

Troponin negative before coronary angiography
My ABCD-GENE score is 10 or higher.
I have stable heart artery disease and am scheduled for a procedure to open my heart's arteries.
See 2 more

Exclusion Criteria

Known platelet count <80x106/mL
Known hemoglobin <9 g/dL
Women of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR who have a positive pregnancy test at enrollment or randomization OR women who are breast-feeding
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose ticagrelor or clopidogrel to assess antiplatelet effects

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

Follow-up

Participants are monitored for safety and effectiveness after treatment, including platelet reactivity measurements

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Clopidogrel
  • Ticagrelor
Trial Overview The study compares the effects of two blood-thinning medications in preventing clot formation after PCI: Ticagrelor (60 mg twice daily) versus Clopidogrel. It aims to see if Ticagrelor offers better protection against platelet reactivity in high-risk genetic profile patients.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-dose ticagrelorExperimental Treatment1 Intervention
Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel.
Group II: ClopidogrelActive Control1 Intervention
Stable CAD patients undergoing elective PCI treated with standard of care clopidogrel will be randomly assigned in a 1:1 fashion to either switch to ticagrelor or continue with clopidogrel.

Ticagrelor is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Brilinta for:
  • Acute coronary syndrome (ACS)
  • Cardiovascular event prevention
  • Coronary artery disease (CAD)
  • Acute ischemic stroke
  • Transient ischemic attack (TIA)
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Approved in European Union as Brilique for:
  • Acute coronary syndrome (ACS)
  • Cardiovascular event prevention
  • Coronary artery disease (CAD)
  • Acute ischemic stroke
  • Transient ischemic attack (TIA)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Scott R. MacKenzie Foundation

Collaborator

Trials
5
Recruited
510+

Findings from Research

In a study of 81 cardiac surgical patients, those who continued taking ticagrelor with acetylsalicylic acid (ASA) until surgery experienced significantly higher blood loss and required more blood product transfusions compared to those on clopidogrel with ASA.
Despite the increased bleeding and transfusion needs in the ticagrelor group, there were no significant differences in intensive care unit stay, hospital stay, or mortality rates, indicating that while ticagrelor may pose bleeding risks, it does not adversely affect overall survival or recovery in the short term.
Perioperative outcomes of cardiac surgery patients with ongoing ticagrelor therapy: boon and bane of a new drug.Schotola, H., Bräuer, A., Meyer, K., et al.[2018]
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.
Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes.Wijeyeratne, YD., Joshi, R., Heptinstall, S.[2022]
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.
Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome.Fuller, R., Chavez, B.[2021]

References

Perioperative outcomes of cardiac surgery patients with ongoing ticagrelor therapy: boon and bane of a new drug. [2018]
Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. [2022]
Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]
Ticagrelor: a review of its use in adults with acute coronary syndromes. [2018]
Ticagrelor-Induced Syncope/Bradyarrhythmia. [2021]
Ticagrelor FDA approval issues revisited. [2018]
[Medication of the month. Ticagrelor (Brilique): potent oral antagonist of platelet activity]. [2018]
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