Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04937699
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2021-06-16
Brief Title:
Sequential MonotherApy of TicagrElor and Clopidogrel After Coronary Intervention
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Efficacy and Safety of Sequential Monotherapy of Ticagrelor and Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention With Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
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:
MATE
Brief Summary:
The MATE study is a randomized multicenter open-label investigator-initiated clinical trial aimed to evaluate efficacy and safety of sequential monotherapy of ticagrelor and clopidogrel in patients with acute coronary syndrome ACS after coronary intervention Standard DAPT of aspirin plus ticagrelor will be given for the first 1 month after PCI After 1 month event-free subjects will be randomized at 11 ratio into receiving standard DAPT DAPT until 12months or switch to ticagrelor monotherapy for another 5 months and further de-escalated to monotherapy of clopidogrel for the last 6 monthsSAPT
Detailed Description:
Compared with clopidogrel ticagrelor inhibit platelet aggregation faster and stronger and significantly reduce the risk of cardiovascular and cerebrovascular adverse events In recent years it has been given the strongest recommendation for antiplatelet therapy in ACS patients Nevertheless it was shown that excessive bleeding events significantly affect its antithrombotic advantage and better safety by downgrading regimen can seek more net clinical benefit However there are still huge controversies regarding the degree or timing of the downgrading regimen
GLOBAL LEADERS study shortened the course of DAPT after PCI to 1 month in all-comer population of coronary heart disease and then downgraded to ticagrelor monotherapy and continued 23 months At 12 months compared with standard DAPT there was neither increased risk of thrombotic events nor significant reduction in BARC3 or type 5 major bleeding events which suggested satisfactory safety of 1-month DAPT and relative insufficiency de-escalation The most recent STOPDAPT-2 ACS study not only adapted 1-month DAPT prasugrel or clopidogrel aspirin in ACS patients but also directly downgraded to clopidogrel monotherapy Compared with standard DAPT of clopidogrel aspirin clopidogrel monotherapy significantly reduces the risk of bleeding however it also increases the thrombotic risk Overrall the investigators believe that de-escalated antiplatelet therapy are most suitable in ACS patients undergoing PCI Short-course DAPT based on potent P2Y12 inhibitors will not increase the thrombotic risk but continuous application of one single P2Y12 receptor antagonists may be difficult to take into account both the antithrombotic efficacy and bleeding benefit while the sequential monotherapy of ticagrelor and clopidogrel may be more conducive to balancing the two needs
In summary the current project aimed atall-comerpopulation of ACS for the first time proposed a de-escalated antiplatelet regimen of sequential monotherapy of ticagrelor and clopidogrel In this project ticagrelor monotherapy will be used 1 month after PCI and the anti-platelet strength will be further downgraded 5 months later to clopidogrel 75 mg monotherapy till 1 year which is supposed to achieve a better safety benefit and a non-inferior efficacy
GLOBAL LEADERS study shortened the course of DAPT after PCI to 1 month in all-comer population of coronary heart disease and then downgraded to ticagrelor monotherapy and continued 23 months At 12 months compared with standard DAPT there was neither increased risk of thrombotic events nor significant reduction in BARC3 or type 5 major bleeding events which suggested satisfactory safety of 1-month DAPT and relative insufficiency de-escalation The most recent STOPDAPT-2 ACS study not only adapted 1-month DAPT prasugrel or clopidogrel aspirin in ACS patients but also directly downgraded to clopidogrel monotherapy Compared with standard DAPT of clopidogrel aspirin clopidogrel monotherapy significantly reduces the risk of bleeding however it also increases the thrombotic risk Overrall the investigators believe that de-escalated antiplatelet therapy are most suitable in ACS patients undergoing PCI Short-course DAPT based on potent P2Y12 inhibitors will not increase the thrombotic risk but continuous application of one single P2Y12 receptor antagonists may be difficult to take into account both the antithrombotic efficacy and bleeding benefit while the sequential monotherapy of ticagrelor and clopidogrel may be more conducive to balancing the two needs
In summary the current project aimed atall-comerpopulation of ACS for the first time proposed a de-escalated antiplatelet regimen of sequential monotherapy of ticagrelor and clopidogrel In this project ticagrelor monotherapy will be used 1 month after PCI and the anti-platelet strength will be further downgraded 5 months later to clopidogrel 75 mg monotherapy till 1 year which is supposed to achieve a better safety benefit and a non-inferior efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None