Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01626534
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2012-03-16
Brief Title:
Evaluation of Ticagrelor Anti Platelet and Pleiotropic Effects in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Evaluation of Ticagrelor Anti Platelet and Pleiotropic Effects in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2014-08
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:
Ticagrelor is a new P2Y12 ADP receptor antagonist This drug demonstrated a faster onset of action and a higher potency compared to clopidogrel standard regimen Consistently these properties were associated in the PLATO trial and particularly in the percutaneous coronary intervention PCI arm of the study with a lower incidence of thrombotic complications at one year follow-up but at a price of increased major bleedings 78 The major finding of the trial was a significant reduction in one year mortality in patients treated with ticagrelor This reduction in mortality may not be related to the anti-platelet effect of the drug since another potent anti-platelet agent which was recently commercialized a did not exhibit any improvement in death compared to clopidogrel Therefore there may be non anti platelet directed properties or pleiotropic effects of ticagrelor that could be involved in a reduction in mortality in acute coronary syndrome ACS patients In fact together with its anti platelet properties ticagrelor has been shown to inhibit the uptake of adenosine by red cells leading to an increase in adenosine plasma level and then activating the low affinity adenosine receptor thus potentially affecting the vascular homeostasis including endothelial cells Therefore it is hypothesis that the side effects and its benefit on mortality may be related to its interaction with adenosine metabolism In line with this hypothesis some adverse effects of ticagrelor bradycardia and modulation of bronchoconstriction are compatible with the activation of low affinity A1 or A2A adenosine receptors
In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact the endothelial compartment during PCI 9 In fact the investigators have observed that the level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of endothelial damage during PCI More potent anti platelet drugs such as ticagrelor may thus be associated with reduced peri-procedural endothelial lesion which could further improve the clinical prognosis of patients The investigators have previously observed that endothelial marker of lesion and regeneration could be measured in the blood post PCI 10
Finally in the response trial no patients in the ticagrelor arm had HTPR compared to 50 in the clopidogrel arm 7 This finding is surprising since recent data suggest that some patients still exhibit HTPR following the use of the very potent third generation thienopyridine prasugrel This may be related to the fact that in the response trial only stable patients were included
The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary intervention
In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact the endothelial compartment during PCI 9 In fact the investigators have observed that the level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of endothelial damage during PCI More potent anti platelet drugs such as ticagrelor may thus be associated with reduced peri-procedural endothelial lesion which could further improve the clinical prognosis of patients The investigators have previously observed that endothelial marker of lesion and regeneration could be measured in the blood post PCI 10
Finally in the response trial no patients in the ticagrelor arm had HTPR compared to 50 in the clopidogrel arm 7 This finding is surprising since recent data suggest that some patients still exhibit HTPR following the use of the very potent third generation thienopyridine prasugrel This may be related to the fact that in the response trial only stable patients were included
The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary intervention
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-22 | OTHER | AP HM | None |