Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting

Summary

The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the reduction in death in a meta-analysis. The field of elective PCI (stable patients) has not been studied with these 2 new drugs and clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported by scientific evidence. More than half of PCI patients undergo elective stenting for proven ischemia and/or stable angina, a relatively safe procedure with the use of the latest generation of stents. However complications remain either frequent when considering PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for improvement with these two newest drugs. The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and myocardial injury) without significant excess bleeding (BARC definition).

Timeline

Start

2017-01-09

Primary completion

2020-05-29

Completion

2020-09-15

Publications

• Giovachini L, Ferrante A, Guedeney P, Rahoual G, Procopi N, Barthelemy O, Kerneis M, Zeitouni M, El Kasty M, Cayla G, Beygui F, Range G, Motovska Z, Laredo M, Dumaine R, Ducrocq G, Rouanet S, Portal JJ, Vicaut E, Montalescot G, Silvain J; ALPHEUS investigators* of the ACTION Group. Impacts of stent characteristics on periprocedural ischemic events in elective PCI: the ALPHEUS-stents study. Int J Cardiol. 2026 Aug 1;456:134506. doi: 10.1016/j.ijcard.2026.134506. Epub 2026 Apr 16.
• Zeitouni M, Montalescot G, Roule V, Guedeney P, Georges JL, Bellemain-Appaix A, Hauguel-Moreau M, Le Breton H, Saint-Etienne C, Caussin C, Montsegu JJ, Maillard L, Isaaz K, Cuisset T, Bressollette E, Schiele F, Cayla G, Beygui F, Range G, Motovska Z, Portal JJ, Vicaut E, Collet JP, Silvain J; ALPHEUS Investigators of the ACTION Group. Definition and Prediction of Periprocedural Myocardial Infarction in Elective Percutaneous Coronary Intervention: The ALPHEUS-MI Study. Can J Cardiol. 2026 Feb 27:S0828-282X(26)00140-6. doi: 10.1016/j.cjca.2026.02.023. Online ahead of print.
• Silvain J, Lattuca B, Beygui F, Range G, Motovska Z, Dillinger JG, Boueri Z, Brunel P, Lhermusier T, Pouillot C, Larrieu-Ardilouze E, Boccara F, Labeque JN, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Collet JP, Cayla G, Blanchart K, Kala P, Vicaut E, Montalescot G; ALPHEUS investigators. Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial. Lancet. 2020 Nov 28;396(10264):1737-1744. doi: 10.1016/S0140-6736(20)32236-4. Epub 2020 Nov 14.
• Silvain J, Cayla G, Beygui F, Range G, Lattuca B, Collet JP, Dillinger JG, Boueri Z, Brunel P, Pouillot C, Boccara F, Christiaens L, Labeque JN, Lhermusier T, Georges JL, Bellemain-Appaix A, Le Breton H, Hauguel-Moreau M, Saint-Etienne C, Caussin C, Jourda F, Motovska Z, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Vicaut E, Montalescot G; ALPHEUS study group. Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study. Am Heart J. 2020 Jul;225:27-37. doi: 10.1016/j.ahj.2020.04.017. Epub 2020 Apr 29.

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Indications