Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02049762
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2014-01-28
Brief Title:
Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
Thus far no study has evaluated the impact on aspirin in addition to the newer and more potent P2Y12 inhibitors among ACS patients and current guidelines recommend dual anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population
Objective The investigators goal is to examine the effect of aspirin in addition to new anti-platelet agent ticagrelorprasugrel on platelet reactivity in comparison with placebo among ACS patients treated percutaneously
Design The proposed study is a randomized-controlled double blind trial conducted among ACS patients treated percutaneously Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention PCI and randomization by envelopes on 11 basis will take place a month after the index event at a follow-up visit at the cardiac clinic
Platelet function and Endothelial function tests will be taken a month after the index event and at a 2 weeks periods following aspirinplacebo therapy cross-over and return to open-label aspirin
End-points platelet function tests will be compared between aspirin and placebo therapy and before and after the cross-over
Objective The investigators goal is to examine the effect of aspirin in addition to new anti-platelet agent ticagrelorprasugrel on platelet reactivity in comparison with placebo among ACS patients treated percutaneously
Design The proposed study is a randomized-controlled double blind trial conducted among ACS patients treated percutaneously Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention PCI and randomization by envelopes on 11 basis will take place a month after the index event at a follow-up visit at the cardiac clinic
Platelet function and Endothelial function tests will be taken a month after the index event and at a 2 weeks periods following aspirinplacebo therapy cross-over and return to open-label aspirin
End-points platelet function tests will be compared between aspirin and placebo therapy and before and after the cross-over
Detailed Description:
Introduction
Current knowledge and data support the use of dual anti-platelets for patients after acute coronary syndrome ACS Novel P2Y12 inhibitors have shown their superiority on clopidogrel in regarding morbidity and mortality but at the cost of higher bleeding rates - even in lower doses of aspirin there is increase risk for gastrointestinal GI bleeding In a geographical analysis of the PLATO trial it has been shown difference at outcome When higher dose of aspirin were used the superiority of ticagrelor was reduced
The use of platelet reactivity tests have been proved and acknowledged in their usefulness for gauging bleeding and ischemic risks Few studies have shown that clopidogral is inhibiting not only the ADP activity but also the arachidonic acid AA pathway that is considered aspirin specific pathway Examining the effect of potent P2Y12 inhibitors in healthy volunteers have shown increased inhibition of the AA pathway Not only that the adding of aspirin have shown little effect on inhibition of AA pathway
It has been demonstrated that vascular endothelial function is inversely correlated to platelet reactivity in both individuals without established cardiovascular disease controls and acute myocardial infarction patients
Objective Our goal is to examine the effect platelet function test and endothelial function of aspirin while added to novel P2Y12 inhibitors treated ACS patients
Design The proposed study is a randomized-controlled double blind trial conducted among ACS patients treated percutaneously Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention PCI and randomization by envelopes on 11 basis will take place a month after the index event at a follow-up visit at the cardiac clinic
Platelet function and Endothelial function tests will be taken a month after the index event and at a 2 weeks periods following aspirinplacebo therapy cross-over and return to open-label aspirin
Study end-points The primary end-point is platelet function tests in response to AA Secondary end-points will include endothelial function and platelet reactivity according to the platelet activity and VerifyNow test in response to ADP and platelet activation Clinical outcomes including all-cause and cardiac mortality and hospitalizations recurrent ischemia and stent thrombosis and bleeding events along with blood transfusions will be recorded as safety end-points
Current knowledge and data support the use of dual anti-platelets for patients after acute coronary syndrome ACS Novel P2Y12 inhibitors have shown their superiority on clopidogrel in regarding morbidity and mortality but at the cost of higher bleeding rates - even in lower doses of aspirin there is increase risk for gastrointestinal GI bleeding In a geographical analysis of the PLATO trial it has been shown difference at outcome When higher dose of aspirin were used the superiority of ticagrelor was reduced
The use of platelet reactivity tests have been proved and acknowledged in their usefulness for gauging bleeding and ischemic risks Few studies have shown that clopidogral is inhibiting not only the ADP activity but also the arachidonic acid AA pathway that is considered aspirin specific pathway Examining the effect of potent P2Y12 inhibitors in healthy volunteers have shown increased inhibition of the AA pathway Not only that the adding of aspirin have shown little effect on inhibition of AA pathway
It has been demonstrated that vascular endothelial function is inversely correlated to platelet reactivity in both individuals without established cardiovascular disease controls and acute myocardial infarction patients
Objective Our goal is to examine the effect platelet function test and endothelial function of aspirin while added to novel P2Y12 inhibitors treated ACS patients
Design The proposed study is a randomized-controlled double blind trial conducted among ACS patients treated percutaneously Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention PCI and randomization by envelopes on 11 basis will take place a month after the index event at a follow-up visit at the cardiac clinic
Platelet function and Endothelial function tests will be taken a month after the index event and at a 2 weeks periods following aspirinplacebo therapy cross-over and return to open-label aspirin
Study end-points The primary end-point is platelet function tests in response to AA Secondary end-points will include endothelial function and platelet reactivity according to the platelet activity and VerifyNow test in response to ADP and platelet activation Clinical outcomes including all-cause and cardiac mortality and hospitalizations recurrent ischemia and stent thrombosis and bleeding events along with blood transfusions will be recorded as safety end-points
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