Ignite Creation Date:
2024-05-06 @ 3:07 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02201667
Status:
UNKNOWN
Last Update Posted:
2014-08-04
First Post:
2014-07-24
Brief Title:
Efficacy of Ticagrelor vs Clopidogrel in High-risk NSTE-ACS Patients Undergoing Early PCI
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
An Open-label Study Evaluating the Acute Efficacy of Treatment With Ticagrelor Versus Clopidogrel on Myocardial Tissue-level Perfusion Assessed by TMPFC and MRI in Patients With High-risk NSTE-ACS Undergoing Early PCIEARLY-MYO II
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The goal of acute coronary syndrome ACS therapy is to successfully restore both epicardial blood flow and myocardial perfusion Percutaneous coronary intervention PCI has been documented as being the most effective method for restoration of epicardial blood flow However epicardial blood flow does not necessarily equate to myocardial perfusion Clopidogrel binds irreversibly to platelet P 2 Y 12 receptors to inhibit platelet aggregation with main limitations of slow onset prevention of recovery of platelet functions and interindividual variability Clinical pharmacology and early dose-finding studies suggested a faster onset and greater and more consistent inhibition of platelet aggregation IPA with ticagrelor compared with clopidogrel Two currently main methods of angiographic assessment of myocardial perfusion includes thrombolysis in myocardial infarctionTIMI myocardial perfusion grading TMPG and myocardial blush grading MBG These established myocardial perfusion parameters have been widely used in various important trials and are reported to be highly useful in predicting clinical outcomes However visual assessment of these methods is categorical subjective and operator dependent of contrast in the myocardium using cine-angiographic frame-counting was developed by the investigators center to quantify myocardial tissue- level perfusion and was proved to be a predictive value on clinical prognosis
Thus the investigators aim to initiate an open-label study evaluating the acute efficacy of treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by Myocardial Perfusion Frame CountTMPFC and magnetic resonance imaging MRI in patients with high-risk non-ST elevation acute coronary syndrome NSTE-ACS undergoing early percutaneous coronary intervention PCI
The investigators hypothesize that compared with clopidogrel ticagrelor can significantly improve myocardial perfusion assessed by Myocardial Perfusion Frame CountTMPFC in high-risk non-ST elevation acute coronary syndrome NSTE-ACS patients undergoing early percutaneous coronary intervention PCI without additional increased major bleeding
Thus the investigators aim to initiate an open-label study evaluating the acute efficacy of treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by Myocardial Perfusion Frame CountTMPFC and magnetic resonance imaging MRI in patients with high-risk non-ST elevation acute coronary syndrome NSTE-ACS undergoing early percutaneous coronary intervention PCI
The investigators hypothesize that compared with clopidogrel ticagrelor can significantly improve myocardial perfusion assessed by Myocardial Perfusion Frame CountTMPFC in high-risk non-ST elevation acute coronary syndrome NSTE-ACS patients undergoing early percutaneous coronary intervention PCI without additional increased major bleeding
Detailed Description:
The goal of acute coronary syndrome ACS therapy is to successfully restore both epicardial blood flow and myocardial perfusion Percutaneous coronary intervention PCI has been documented as being the most effective method for restoration of epicardial blood flow However epicardial blood flow does not necessarily equate to myocardial perfusion not every patient with thrombolysis in myocardial infarctionTIMI 3 flow after successful percutaneous coronary intervention PCI achieves effective myocardial tissue-level perfusion Although epicardial thrombolysis in myocardial infarctionTIMI 3 flow could be restored in 90 of acute coronary syndrome ACS patients undergoing percutaneous coronary intervention PCI normalization of myocardial perfusion was achieved less frequently with detrimental impacts on survival
Clopidogrel the most widely used antiplatelet agent in acute coronary syndrome ACS is a thienopyridine prodrug which is inactive until in undergoes biotransformation into its active metabolite which then binds irreversibly to platelet P 2 Y 12 receptors This irreversible binding means that the receptors are inhibited for the lifespan of the platelet The main limitations of clopidogrel administration include slow onset prevention of recovery of platelet functions and interindividual variability
Clinical pharmacology and early dose-finding studies suggested a faster onset and greater and more consistent inhibition of platelet aggregation IPA with ticagrelor compared with clopidogrel ONSETOFFSET study showed that in patients with stable coronary artery disease on aspirin ticagrelor demonstrates a rapid onset of pharmacological effect as demonstrated by a mean platelet aggregation IPA for ticagrelor at 05 h after 180 mg loading dose of about 41 with the maximum platelet aggregation IPA effect of 879-896 by 2-4 hours post dose A total of 90 of patients had final extent Inhibition of platelet aggregation IPA 70 by 2 h post-dose The high inhibition of platelet aggregation IPA effect of ticagrelor between 87 and 89 was maintained for 2-8 hours Ticagrelor might overcome the slow-onset limitation of clopidogrel and bring extra benefit for improving myocardial perfusion in the acute phase of acute coronary syndrome ACS when undergoing early percutaneous coronary intervention PCI
Currently there are two main methods of angiographic assessment of myocardial perfusion Thrombolysis in myocardial infarction TIMI myocardial perfusion grading TMPG described by Gibson et al and myocardial blush grading MBG described by Vant Hof et al These established myocardial perfusion parameters myocardial perfusion grading TMPG and myocardial blush grading MBG have been widely used in various important trials and are reported to be highly useful in predicting clinical outcomes However visual assessment of these methods is categorical subjective and operator dependent Thrombolysis in myocardial infarctionTIMI Myocardial Perfusion Frame Count TMPFC a novel and objective method that measures the filling and clearance of contrast in the myocardium using cine-angiographic frame-counting was developed by the investigators center to quantify myocardial tissue- level perfusion and was proved to be a predictive value on clinical prognosis
Thus the investigators aim to initiate an open-label study evaluating the acute efficacy of treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by Myocardial Perfusion Frame Count TMPFC and magnetic resonance imaging MRI in patients with high-risk non-ST elevation acute coronary syndrome NSTE-ACS undergoing early percutaneous coronary intervention PCI
Clopidogrel the most widely used antiplatelet agent in acute coronary syndrome ACS is a thienopyridine prodrug which is inactive until in undergoes biotransformation into its active metabolite which then binds irreversibly to platelet P 2 Y 12 receptors This irreversible binding means that the receptors are inhibited for the lifespan of the platelet The main limitations of clopidogrel administration include slow onset prevention of recovery of platelet functions and interindividual variability
Clinical pharmacology and early dose-finding studies suggested a faster onset and greater and more consistent inhibition of platelet aggregation IPA with ticagrelor compared with clopidogrel ONSETOFFSET study showed that in patients with stable coronary artery disease on aspirin ticagrelor demonstrates a rapid onset of pharmacological effect as demonstrated by a mean platelet aggregation IPA for ticagrelor at 05 h after 180 mg loading dose of about 41 with the maximum platelet aggregation IPA effect of 879-896 by 2-4 hours post dose A total of 90 of patients had final extent Inhibition of platelet aggregation IPA 70 by 2 h post-dose The high inhibition of platelet aggregation IPA effect of ticagrelor between 87 and 89 was maintained for 2-8 hours Ticagrelor might overcome the slow-onset limitation of clopidogrel and bring extra benefit for improving myocardial perfusion in the acute phase of acute coronary syndrome ACS when undergoing early percutaneous coronary intervention PCI
Currently there are two main methods of angiographic assessment of myocardial perfusion Thrombolysis in myocardial infarction TIMI myocardial perfusion grading TMPG described by Gibson et al and myocardial blush grading MBG described by Vant Hof et al These established myocardial perfusion parameters myocardial perfusion grading TMPG and myocardial blush grading MBG have been widely used in various important trials and are reported to be highly useful in predicting clinical outcomes However visual assessment of these methods is categorical subjective and operator dependent Thrombolysis in myocardial infarctionTIMI Myocardial Perfusion Frame Count TMPFC a novel and objective method that measures the filling and clearance of contrast in the myocardium using cine-angiographic frame-counting was developed by the investigators center to quantify myocardial tissue- level perfusion and was proved to be a predictive value on clinical prognosis
Thus the investigators aim to initiate an open-label study evaluating the acute efficacy of treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by Myocardial Perfusion Frame Count TMPFC and magnetic resonance imaging MRI in patients with high-risk non-ST elevation acute coronary syndrome NSTE-ACS undergoing early percutaneous coronary intervention PCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None