A Phase 4 interventional study of Standard-DAPT of Ticagrelor plus aspirin and Sequential monotherapy of Ticagrelor and clopidogrel in Acute Coronary Syndrome and Percutaneous Coronary Intervention, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment
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 1:1 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 months(SAPT).
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 at"all-comer"population 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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 2,690 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
Patients will receive Standard-DAPT of Ticagrelor plus aspirin for 1month after PCI and continue to receive standard-DAPT till 1 year in this arm after as followed: Ticagrelor 90mg bid+Aspirin 100mg qd for 1month; Ticagrelor 90mg bid+Aspirin 100mg qd for another 11 months;
Drug: Standard-DAPT of Ticagrelor plus aspirin
Patients will receive Standard-DAPT of Ticagrelor plus aspirin for 1month after PCI and switch to ticagrelor monotherapy in the following 5 months, and then further de-escalated to clopidogrel monotherapy till 1 year in this arm as followed: Ticagrelor 90mg bid+Aspirin 100mg qd for 1 month; Ticagrelor 90mg bid, for 5 months; clopidogrel 75mg qd, for 6 months.
Drug: Sequential monotherapy of Ticagrelor and clopidogrel
Ticagrelor 90mg bid+Aspirin 100mg qd for 1 month after PCI, Randomized subjects continue for another 11 months
Also known as: DAPT
Ticagrelor 90mg bid+Aspirin 100mg qd for 1 month after PCI, Randomized subjects switch to ticagrelor 90mg bid for 5 months; then clopidogrel 75mg qd, for another 6 months.
Also known as: SAPT
NACCE
Cumulative incidence of cardiovascular death, myocardial infarction, stroke (ischaemic, haemorrhagic, or unknown aetiology), definite stent thrombosis and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria.
Time frame: 1-12months after PCI (11 months after randomization)
MACCE
The Key secondary endpoint for ischemic outcome is cumulative incidence of cardiovascular death, non-fatal myocardial infarction,definite stent thrombosis or stroke (ischaemic, haemorrhagic, or unknown aetiology)
Time frame: 1-12months after PCI (11 months after randomization)
BARC types 2,3 or 5 bleeding
The Key secondary endpoint for bleeding outcome is cumulative incidence of BARC types 2,3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria.
Time frame: 1-12months after PCI (11 months after randomization)
Plan to share: Yes — The deidentified data will be shared after publication of first manuscript
Supporting information: Study protocol
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Second Affiliated Hospital, School of Medicine, Zhejiang University