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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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 established role in the prevention of atherothrombotic events in ACS setting. However, DAPT in older patients is challenged by a concurrent heightened risk of ischemia and bleeding. Although guidelines recommend DAPT with aspirin and ticagrelor for elderly patients with ACS, clopidogrel, a less potent antiplatelet agent, continues to be used in more than one third of ACS patients with elderly status being the strongest predictor of undertreatment. A lower dose of ticagrelor may represent an alternative to the standard dose by conferring a similar efficacy and, potentially, a better safety profile. Our prospective, randomized, double-blind, crossover trial will test the hypothesis that a lower dose of ticagrelor provides similar antiplatelet effects compared with a standard dose among elderly patients with ACS.

The main aim of the trial is to determine the pharmacodynamic and pharmacokinetic profile of ticagrelor 60 mg twice daily versus ticagrelor 90 mg twice daily among elderly patients with ACS undergoing PCI.

This will be a prospective, randomized (1:1 ratio), non-inferiority, open-label, crossover trial to evaluate the level of platelet inhibition achieved with a low-dose of ticagrelor (60 mg twice daily) versus a standard dose of ticagrelor (90 mg twice daily) among elderly patients with ACS undergoing PCI.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Collaborator: AdvicePharma Group
• Treatments: Ticagrelor

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.