Status:
COMPLETED
Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg in Elderly Patients With ACS
Lead Sponsor:
Federico II University
Collaborating Sponsors:
AdvicePharma Group
Conditions:
Acute Coronary Syndrome
STEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Elderly individuals are increasingly represented among patients with acute coronary syndrome (ACS). Dual antiplatelet therapy (DAPT) with aspirin and an oral P2Y12 receptor inhibitor has an establishe...
Detailed Description
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 le...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent in a time window 1 to 3 days after successful PCI;
- Male or female, age ≥ 75 years at screening;
- ACS at the time of the index hospitalization;
- Use of a loading dose of 180 mg of ticagrelor administered after diagnosis of ACS or after PCI;
- Use of a maintenance dose of 90 mg twice daily of ticagrelor of at least 48 hours after the loading dose;
- 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
- Use of glycoprotein IIb/IIIa receptor inhibitors;
- Need for chronic oral anticoagulant therapy;
- Prior fibrinolysis;
- Unstable clinical status (hemodynamic or electrical instability);
- Planned surgery requiring DAPT discontinuation during the study;
- Prior stroke, transient ischemic attack or intracranial bleeding;
- Active bleeding;
- Severe anemia (hemoglobin \< 8g/dL);
- Platelet count ≤80x103/ml;
- Renal failure (hemodialysis or creatinine clearance ≤ 30 ml/min calculated with Cockroft-Gault formula);
- Severe hepatic dysfunction (baseline alanine aminotransferase ≥ 2.5 times the upper limit of normal);
- Known hypersensitivity or contraindication to ticagrelor;
- Under judicial protection, tutorship or curatorship;
- Unable to understand and follow study-related instructions;
- Enrollment in another investigational device or drug study.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04739384
Start Date
April 1 2021
End Date
June 20 2022
Last Update
July 7 2022
Active Locations (1)
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1
Professor Giovanni Esposito
Naples, Italy, 80131