Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02617290
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2015-09-15
Brief Title:
Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting The ALPHEUS Study
Status:
COMPLETED
Status Verified Date:
2020-10
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:
ALPHEUS
Brief Summary:
The new P2Y12 inhibitors prasugrel Efient-Effient and ticagrelor Brilique-Brilinta have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS ESC Guidelines Class 1 LOE B These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention PCI by the dramatic diminution of stent thrombosis the reduction in death or Myocardial Infarction MI as well as the reduction in death in a meta-analysis
The field of elective PCI stable patients has not been studied with these 2 new drugs and clopidogrel remains the standard of care However off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI left main diabetics multiple stenting high risk of stent thrombosis no clopidogrel pretreatment but is not supported by scientific evidence More than half of PCI patients undergo elective stenting for proven ischemia andor stable angina a relatively safe procedure with the use of the latest generation of stents However complications remain either frequent when considering PCI-related myonecrosismyocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis Q wave MI or stroke leaving room for improvement with these two newest drugs
The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint peri-procedural MI and myocardial injury without significant excess bleeding BARC definition
The field of elective PCI stable patients has not been studied with these 2 new drugs and clopidogrel remains the standard of care However off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI left main diabetics multiple stenting high risk of stent thrombosis no clopidogrel pretreatment but is not supported by scientific evidence More than half of PCI patients undergo elective stenting for proven ischemia andor stable angina a relatively safe procedure with the use of the latest generation of stents However complications remain either frequent when considering PCI-related myonecrosismyocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis Q wave MI or stroke leaving room for improvement with these two newest drugs
The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint peri-procedural MI and myocardial injury without significant excess bleeding BARC definition
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