NCT04937699RecruitingPhase 4
Sequential MonotherApy of TicagrElor and Clopidogrel After Coronary Intervention
Efficacy and Safety of Sequential Monotherapy of Ticagrelor and Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention With Acute Coronary Syndrome
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2690 (estimated)
- First submitted
- 16 Jun 2021
- Start date
- 28 Mar 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Coronary artery disease
- NCT number
- NCT04937699
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2690
- From 28 Mar 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Thrombolytic therapy within 24 hours of index PCI;
- Planned coronary revascularization (surgical or percutaneous) within 30 days;
- Required use of oral anticoagulation (warfarin or other factor II or factor X inhibitors);
- Participating in any other clinical trial of an investigational drug or device that has not met its primary endpoint.
Other illness
- Patients with active pathological bleeding (such as peptic ulcer or intracranial hemorrhage);
- History of intracranial hemorrhage, intracranial neoplasms, intracranial vascular malformations or hemangioma
- High potential risk of major bleeding, such as acute or chronic gastrointestinal ulcers or other gastrointestinal diseases, alignant tumors, etc.;
- Allergic to ticagrelor, clopidogrel or aspirin and any excipients;
- Diagnosed as active hepatitis or liver cirrhosis upon admission;
- Suffer from a known serious progressive disease (e.g. progressive cancer, chronic obstructive lung disease, etc.;) or estimated survival time\<12 months ;
- Dialysis-dependent renal failure;
- Any condition that may interfere with any study procedures, such as dementia, immobility, alcohol use, etc;
Lab values
- Platelet count\<100000 /mm3;
Other
- Implanted with first-generation DES or bioabsorbable stent(s) during hospitalization;
- Inability to tolerate 12-month DAPT (ticagrelor+aspirin) for any reason;
- Cardiogenic shock or hemodynamic instability;
- Pregnant or plan to be pregnant within 1 year;
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine at Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.