Ticagrelor vs. Clopidogrel for Coronary Artery Disease
Recruiting in Palo Alto (17 mi)
Overseen byFrancesco Franchi, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Florida
Must be taking: Aspirin, Clopidogrel
Must not be taking: Prasugrel, Ticagrelor
Disqualifiers: Myocardial infarction, Anticoagulants, Liver disease, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12456What 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.
12457Eligibility 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
I am 18 years old or older.
Troponin negative before coronary angiography
My ABCD-GENE score is 10 or higher.
+3 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
+12 more
Trial 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)
Participant Groups
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.
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)
🇪🇺 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
Research Locations NearbySelect from list below to view details:
University of Florida JacksonvilleJacksonville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
Scott R. MacKenzie FoundationCollaborator
References
Perioperative outcomes of cardiac surgery patients with ongoing ticagrelor therapy: boon and bane of a new drug. [2018]Ticagrelor (Brilique®) is a novel reversible platelet inhibitor at P2Y12 receptor used in patients with acute coronary syndrome and patients undergoing percutaneous coronary interventions. Unlike clopidogrel (Plavix®), ticagrelor has a quicker offset of action, and therefore, it seems that platelet function recovers faster on discontinuation of therapy. These drugs sometimes cannot be stopped before coronary artery bypass grafting due to the risk of stent thrombosis or in case of emergency operations. Therefore, we investigated whether the continued preoperative use of ticagrelor influences the perioperative course of cardiac surgical patients.
Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. [2022]Agents that inhibit platelet function are used routinely in the treatment and prevention of acute coronary syndromes. The main antiplatelet treatments used combine aspirin with one of the thienopyridine P2Y(12) antagonists, either clopidogrel or prasugrel. By blocking the synthesis of thromboxane A(2) in platelets and by blocking the effects of ADP, respectively, these agents reduce platelet activity, platelet aggregation and thrombus formation. Ticagrelor (marketed by AstraZeneca as Brilinta™ in the USA, and as Brilique(®) or Possia(®) in Europe) is a cyclopentyl-triazolo-pyrimidine, a new chemical class of P2Y(12) antagonist that is now approved for use in the wide spectrum of acute coronary syndromes. In this article we provide an overview of ticagrelor. We discuss the differences in mode of action compared with other P2Y(12) antagonists, examine its pharmacodynamic, pharmacokinetic and safety profile, and summarize the various clinical trials that have provided information on its efficacy in combination with aspirin. Ticagrelor appears to overcome some of the difficulties that have been encountered with other antiplatelet treatments, clopidogrel in particular.
Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]Ticagrelor (Brilinta) for acute coronary syndrome.
Ticagrelor: a review of its use in adults with acute coronary syndromes. [2018]Ticagrelor (Brilique™, Brilinta®), a cyclopentyl-triazolopyrimidine, is an orally active, reversible, and selective adenosine diphosphate (ADP) receptor antagonist indicated for use in patients with acute coronary syndromes (ACS). Ticagrelor has a faster onset of action and provides greater inhibition of platelet aggregation than clopidogrel. In the large well-designed, PLATO study in adult patients with ACS, 12 months' treatment with ticagrelor was more effective than clopidogrel in reducing the incidence of the primary composite endpoint of myocardial infarction, stroke, or cardiovascular (CV) death. Ticagrelor also reduced all-cause mortality relative to clopidogrel, although statistical significance of this was not confirmed in hierarchical testing. Benefit with ticagrelor was seen both in invasively and noninvasively managed patients. Ticagrelor was generally well tolerated and was not associated with an increased risk of major bleeding relative to clopidogrel. However, the incidences of non-coronary artery bypass grafting (CABG)-related bleeding, and major or minor bleeding, as well as some non-hemorrhagic adverse events, including dyspnea (usually of mild or moderate severity) and ventricular pauses (largely asymptomatic) were higher with ticagrelor. In addition, the ATLANTIC study showed that although pre-hospital administration of ticagrelor did not improve pre-percutaneous coronary intervention (PCI) coronary reperfusion in ACS patients relative to in-hospital administration, ticagrelor was safe in both instances, with no significant between-group differences in non-CABG-related major and minor bleeding events. Although further comparative studies with other antiplatelet agents, including prasugrel, are required to position it more definitively, current evidence indicates that ticagrelor is a useful option for the prevention of thrombotic CV events in ACS patients managed invasively or noninvasively.
Ticagrelor-Induced Syncope/Bradyarrhythmia. [2021]Ticagrelor (BRILINTA®) is a very commonly used oral antiplatelet agent in acute coronary syndrome and after percutaneous coronary intervention (PCI). It is a reversible, direct inhibitor of the adenosine diphosphate (ADP) P2Y12 receptor. Most of the patients tolerate the drug well but it is known to cause brady arrhythmias and ventricular pauses, the exact mechanism of which is unclear. We present a case of acute coronary syndrome/unstable angina in a 58-year-old Caucasian gentleman requiring cardiac catheterization and PCI with drug eluting stent deployment and syncope following Ticagrelor loading from long ventricular pauses.
Ticagrelor FDA approval issues revisited. [2018]On July 20, 2011, the Food and Drug Administration (FDA) approved ticagrelor (Brilinta™) for use during acute coronary syndromes. The drug labeling includes a 'black box' warning for bleeding risks, conventional for antithrombotics, and a unique warning that higher than 100 mg/daily maintenance treatment with aspirin may reduce ticagrelor effectiveness. The approval was granted following ticagrelor secondary reviews, and review of complete response by FDA officials.
[Medication of the month. Ticagrelor (Brilique): potent oral antagonist of platelet activity]. [2018]Dual antiplatelet therapy with clopidogrel combined with aspirin reduces ischemic events in acute coronary syndromes (ACS). The individual response to clopidogrel is, however, very variable from one subject to another, and the risk of events seems higher when platelet inhibition is insufficient. Ticagrelor is a potent oral inhibitor of platelet activity. It binds reversibly to the P2Y12 adenosine diphosphate. The platelet inhibition that it induces is faster and more pronounced than that of clopidogrel. In patients who have an ACS (PLATO study) with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, myocardial infarction, or stroke, without an increase in the rate of overall major bleeding but with an increase in the rate of non-procedure-related bleeding. In Belgium, Brilique is currently indicated in combination with aspirin for the prevention of atherothrombotic events in patients with ACS.