NCT04739384: PlinytheElder

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

Completed Phase 3 Last updated 7 July 2022

What this trial tests

Phase 3 trial testing Ticagrelor 90mg in Acute Coronary Syndrome in 50 participants. Completed in 20 June 2022.

Timeline

1 April 2021

Primary endpoint
20 June 2022

20 June 2022

Quick facts

Lead sponsor	Federico II University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 April 2021
Primary completion	20 June 2022
Estimated completion	20 June 2022
Sites	1 location across Italy

Drugs / interventions tested

• Ticagrelor 90mg — full drug profile →
• Ticagrelor 60 mg — full drug profile →

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• STEMI — all drugs for STEMI →
• NSTEMI — all drugs for NSTEMI →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Federico II University

Who can join

18 and older, any sex, with Acute Coronary Syndrome or STEMI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
   Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w
2. Platelet Inhibition with Ticagrelor 60 mg Versus 90 mg Twice Daily in Elderly Patients with Acute Coronary Syndrome: Rationale and Design of the PLINY THE ELDER Trial.
   Piccolo R, Avvedimento M, Canonico ME, Gargiulo P, et al · · 2023 · cited 8× · PMID 35048203 · DOI 10.1007/s10557-021-07302-y
3. Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial.
   Piccolo R, Simonetti F, Avvedimento M, Cutillo M, et al · · 2024 · cited 3× · PMID 39025785 · DOI 10.1093/ehjcvp/pvae054
4. Sex differences among elderly ACS patients undergoing percutaneous coronary intervention receiving Ticagrelor 60 mg vs. 90 mg.
   Piccolo R, Laino A, Vitale AP, Canonico ME, et al · · 2026 · cited 1× · PMID 41243071 · DOI 10.1007/s11239-025-03206-y