Key result
APELOT tests if 360 mg ticagrelor loading improves platelet inhibition vs 180 mg in NSTE-ACS.
Why the study?
The effect of a higher loading dose of ticagrelor on faster and stronger platelet inhibition in NSTE-ACS patients undergoing PCI is unknown and needs further exploration.
Does a high loading dose (360 mg) of ticagrelor improve platelet inhibition compared to a conventional loading dose (180 mg) in NSTE-ACS patients undergoing PCI?
RCT (n=250)
Open-label
Randomized
Yes
Does a high loading dose (360 mg) of ticagrelor improve platelet inhibition compared to a conventional loading dose (180 mg) in NSTE-ACS patients undergoing PCI?
The APELOT trial is designed to evaluate whether a 360 mg loading dose of ticagrelor provides faster and stronger platelet inhibition than the standard 180 mg dose in NSTE-ACS patients undergoing PCI.
Optimal ticagrelor loading dose remains unproven in NSTE-ACS PCI; APELOT RCT will deliver the first direct comparison of 360 mg vs 180 mg.
Ticagrelor is a direct acting on the P2Y12 receptor blocker, which provides faster and greater platelet inhibition than clopidogrel. However, several studies suggested that in ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention (PCI), ticagrelor exhibits initial delay in the onset of antiplatelet action. Unlike ST-segment elevation myocardial infarction, in non-ST-segment elevation acute coronary syndrome (NSTE-ACS), management pathways are highly variable, and some patients may require surgery. Effect of higher loading dose (LD) of ticagrelor in patients with NSTE-ACS in providing faster and stronger inhibition of platelet aggregation is unknown and needs to be explored further.The AntiPlatelet Effect of different Loading dOse of Ticagrelor trial is an interventional, randomized, open-label, multicenter, phase IV trial designed to evaluate whether a high LD (360 mg) of ticagrelor compared with the conventional LD (180 mg) will result in a higher inhibition of platelet aggregation without increasing bleeding events in NSTE-ACS participants undergoing PCI.A total of 250 NSTE-ACS participants will be randomized to receive a ticagrelor LD (360 or 180 mg), followed by a maintenance dose of 90 mg twice a day (bid) starting 12 hours after the LD. The primary endpoint is platelet reactivity index measured by vasodilator-stimulated phosphoprotein phosphorylation 2 hours after the LD, and the secondary endpoints include occurrence of periprocedural myocardial infarction and bleeding events.The AntiPlatelet Effect of different Loading dOse of Ticagrelor trial will provide important information on the risks and benefits of a high LD (360 mg) of ticagrelor in achieving a faster and stronger platelet inhibition compared with the conventional LD (180 mg) in NSTE-ACS patients undergoing PCI.
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Liu et al. (2016) conducted an RCT in Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) undergoing PCI (n=250). Ticagrelor high loading dose vs. Ticagrelor conventional loading dose (180 mg) was evaluated on Platelet reactivity index measured by vasodilator-stimulated phosphoprotein phosphorylation 2 hours after the loading dose. The APELOT trial will randomize 250 NSTE-ACS patients undergoing PCI to evaluate if a 360 mg ticagrelor loading dose provides higher platelet inhibition than a 180 mg dose.
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