NCT04937699 Sequential MonotherApy of TicagrElor and Clopidogrel After Coronary Intervention
| NCT ID | NCT04937699 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,690 participants |
| Start Date | 2023-03-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,690 participants in total. It began in 2023-03-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. Age 18-80 years old; 2. Acute coronary syndrome was diagnosed upon admission; 3. Administered ticagrelor for at least 30 days after successful PCI with implantation of a current-generation drug-eluting stent(s) 4. Agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent Exclusion Criteria: 1. Implanted with first-generation DES or bioabsorbable stent(s) during hospitalization; 2. Patients with active pathological bleeding (such as peptic ulcer or intracranial hemorrhage); 3. History of intracranial hemorrhage, intracranial neoplasms, intracranial vascular malformations or hemangioma 4. High potential risk of major bleeding, such as acute or chronic gastrointestinal ulcers or other gastrointestinal diseases, alignant tumors, etc.; 5. Thrombolytic therapy within 24 hours of index PCI; 6. Planned coronary revascularization (surgical or percutaneous) within 30 days; 7. Allergic to ticagrelor, clopidogrel or aspirin and any excipients; 8. Inability to tolerate 12-month DAPT (ticagrelor+aspirin) for any reason; 9. Cardiogenic shock or hemodynamic instability; 10. Diagnosed as active hepatitis or liver cirrhosis upon admission; 11. Suffer from a known serious progressive disease (e.g. progressive cancer, chronic obstructive lung disease, etc.;) or estimated survival time\<12 months ; 12. Platelet count\<100000 /mm3; 13. Dialysis-dependent renal failure； 14. Required use of oral anticoagulation (warfarin or other factor II or factor X inhibitors); 15. Pregnant or plan to be pregnant within 1 year; 16. Any condition that may interfere with any study procedures, such as dementia, immobility, alcohol use, etc; 17. Participating in any other clinical trial of an investigational drug or device that has not met its primary endpoint.
Contact & Investigator
Yong Sun, MD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT04937699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04937699 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04937699 currently recruiting?
Yes, NCT04937699 is actively recruiting participants. Contact the research team at whysmmu@126.com for enrollment information.
Where is the NCT04937699 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04937699 clinical trial?
NCT04937699 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Yong Sun, MD at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 2,690 participants.