Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03437044
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2018-02-12
Brief Title:
Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Randomized Comparison of Platelet Inhibition Using a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Prior Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention The OPTIMUS Optimizing Antiplatelet Therapy in Diabetes Mellitus-6 Study
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMUS-6
Brief Summary:
To date there is very little PD and pharmacokinetic PK data on the ticagrelor 60 mg bid dosing regimen In particular there is no prospective PKPD study on this dosing regimen in patients with DM who are known to have impaired response to clopidogrel therapy Since DM patients frequently require elective PCI due to chronic progression of CAD and not solely because of an acute thrombotic complication and clopidogrel remains the guideline recommended P2Y12 inhibiting therapy for these patients understanding the PD effects of the ticagrelor 60 mg bid regimen in this setting is an unmet clinical need This is also in light of the ongoing THEMIS trial which is specifically evaluating the impact of the ticagrelor 60 mg bid dosing regimen in type 2 DM patients without a prior major CV event
Detailed Description:
Patients with diabetes mellitus DM are characterized by platelet hyperreactivity and reduced pharmacodynamic PD effects to several oral antiplatelet agents including clopidogrel In addition to the hyperreactive platelet phenotype impaired drug metabolism as well as increased platelet turnover rates may contributed to impaired clopidogrel-induced antiplatelet effects in DM patients These observations may contribute to the higher ischemic event rates including stent thrombosis observed in DM patients compared with non-DM patients treated with clopidogrel
Ticagrelor is characterized by more prompt potent and predictable antiplatelet effects compared with clopidogrel and lower ischemic events in patients with an acute coronary syndrome ACS on a background of aspirin therapy In patients who experienced a prior 1-3 years myocardial infarction MI compared with placebo ticagrelor 60 mg bid on a background of aspirin therapy also reduced long-term ischemic events with a mortality benefit observed in DM patients
To date the PD effects of ticagrelor versus clopidogrel in DM largely derive from post-hoc assessments or in stabilized patients eg 30 days after PCI and have not been prospectively evaluated in the context of elective PCI procedures Moreover PD studies with the ticagrelor 60 mg bid regimen are limited Therefore the aim of this investigation will be to compare the PD effects of a ticagrelor 60 mg bid versus clopidogrel 75 mg od MD regimen in DM patients without a prior major CV event undergoing elective PCI
Ticagrelor is characterized by more prompt potent and predictable antiplatelet effects compared with clopidogrel and lower ischemic events in patients with an acute coronary syndrome ACS on a background of aspirin therapy In patients who experienced a prior 1-3 years myocardial infarction MI compared with placebo ticagrelor 60 mg bid on a background of aspirin therapy also reduced long-term ischemic events with a mortality benefit observed in DM patients
To date the PD effects of ticagrelor versus clopidogrel in DM largely derive from post-hoc assessments or in stabilized patients eg 30 days after PCI and have not been prospectively evaluated in the context of elective PCI procedures Moreover PD studies with the ticagrelor 60 mg bid regimen are limited Therefore the aim of this investigation will be to compare the PD effects of a ticagrelor 60 mg bid versus clopidogrel 75 mg od MD regimen in DM patients without a prior major CV event undergoing elective PCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None