Efficacy and Safety of Sequential Monotherapy of Ticagrelor and Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention With Acute Coronary Syndrome

Who is this study for? Patients with Acute Coronary Syndrome
What treatments are being studied? Ticagrelor 
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years old;

• Acute coronary syndrome was diagnosed upon admission;

• Administered ticagrelor for at least 30 days after successful PCI with implantation of a current-generation drug-eluting stent(s)

• Agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine at Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Heyang Wang, MD
whysmmu@126.com
86 0571-87783759
Backup
Changling Li, MD
HREC2013@126.com
+86 0571 89713104
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2690
Treatments
Active_comparator: Standard-DAPT of Ticagrelor plus aspirin (DAPT)
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;
Experimental: Sequential monotherapy of Ticagrelor and Clopidogrel (SAPT)
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.
Authors
Changling Li
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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