Clinical trial NCT04484259: Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus
Official title: Pharmacodynamic Effects of Different Ticagrelor Maintenance Dosing Regimens With and Without Aspirin in Patients With Diabetes Mellitus: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-7 Study
Conditions: Diabetes Mellitus, Type 2
Coronary Artery Disease
Summary: Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). However, if an aspirin-free approach can be considered after this time frame is a matter of debate. The aim of this study is to assess the PD effects of ticagrelor 60 mg with and without aspirin therapy in CAD patients and to compare this with a standard DAPT regimen of aspirin plus clopidogrel.
Interventions:
description: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
name: Ticagrelor monotherapy
other_name: Brilinta
type: Drug
description: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
name: Ticagrelor plus aspirin
other_name: Brilinta
type: Drug
description: Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
name: Clopidogrel with aspirin
other_name: Plavix
type: Drug
Study arms:
design_group_description: ticagrelor 60 mg bid monotherapy
design_group_title: Ticagrelor
design_group_type: Experimental
design_group_description: aspirin 81 mg qd plus clopidogrel 75 mg qd
design_group_title: Aspirin plus Clopidogrel
design_group_type: Active Comparator
design_group_description: aspirin 81 mg qd plus ticagrelor 60 mg bid
design_group_title: Aspirin plus Ticagrelor
design_group_type: Active Comparator
Sponsor: University of Florida
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 替格瑞洛
lang: CN
name: Ticagrelor
lang: EN
name: チカグレロル
lang: JP