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Search / Trial NCT04739384

Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg in Elderly Patients With ACS

Launched by FEDERICO II UNIVERSITY · Feb 1, 2021

Trial Information

Current as of June 09, 2025

Completed

Keywords

Platelet Aggregation Elderly Patients Ticagrelor

ClinConnect Summary

Elderly individuals account for an increasing proportion of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) given the aging of the population and the lengthening of life expectancy.1, 2 Dual antiplatelet therapy with aspirin and an oral P2Y12 receptor inhibitor is the cornerstone of antithrombotic therapy in patients with ACS undergoing PCI, yet decision-making in older patients remains challenging because of a concomitantly increased risk of bleeding and ischemic complications burdening this population.3 Elderly status may be considered per s...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Ability to provide written informed consent in a time window 1 to 3 days after successful PCI;
  • 2. Male or female, age ≥ 75 years at screening;
  • 3. ACS at the time of the index hospitalization;
  • 4. Use of a loading dose of 180 mg of ticagrelor administered after diagnosis of ACS or after PCI;
  • 5. Use of a maintenance dose of 90 mg twice daily of ticagrelor of at least 48 hours after the loading dose;
  • 6. Successful PCI (Thrombolysis In Myocardial Infarction \[TIMI\] flow 3 and residual coronary stenosis \<30%) for non-ST-segment elevation ACS or ST-segment elevation myocardial infarction
  • Exclusion Criteria:
  • 1. Use of glycoprotein IIb/IIIa receptor inhibitors;
  • 2. Need for chronic oral anticoagulant therapy;
  • 3. Prior fibrinolysis;
  • 4. Unstable clinical status (hemodynamic or electrical instability);
  • 5. Planned surgery requiring DAPT discontinuation during the study;
  • 6. Prior stroke, transient ischemic attack or intracranial bleeding;
  • 7. Active bleeding;
  • 8. Severe anemia (hemoglobin \< 8g/dL);
  • 9. Platelet count ≤80x103/ml;
  • 10. Renal failure (hemodialysis or creatinine clearance ≤ 30 ml/min calculated with Cockroft-Gault formula);
  • 11. Severe hepatic dysfunction (baseline alanine aminotransferase ≥ 2.5 times the upper limit of normal);
  • 12. Known hypersensitivity or contraindication to ticagrelor;
  • 13. Under judicial protection, tutorship or curatorship;
  • 14. Unable to understand and follow study-related instructions;
  • 15. Enrollment in another investigational device or drug study.

About Federico Ii University

Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.

Locations

Naples, , Italy

Patients applied

0 patients applied

Trial Officials

Giovanni Esposito, MD, PhD

Principal Investigator

Federico II University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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