MonotherApy of Low-does TicagrElor After Percutaneous Coronary Intervention

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The MATE study is a randomized, multicenter, open-label, investigator-initiated clinical trial aimed to evaluate efficacy and safety of sequential single antiplatelet therapy of low-dose Ticagrelor and clopidogrel in patients with acute coronary syndrome (ACS) and high bleeding risk after coronary intervention. Eligible patients will be randomized at 1:1 ratio after PCI, into receiving standard-dose ticagrelor DAPT (SD.T) for 12months , or low-dose ticagrelor DAPT for only 1 month, followed by 5 months of low-dose ticagrelor monotherapy, and further de-escalated monotherapy of clopidogrel for another 6 months(LD.T).

The current study is to observe whether the low-does potent P2Y12 inhibitor can largely reduce clinical-relevant bleeding versus dual antiplatelet therapy, while keep non-inferior on thrombotic risk in ACS patients with high bleeding risk.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

1. Age 18-80 years old;

2. Acute coronary syndrome was diagnosed upon admission;

3. Must meet at least one of the following high-risk clinical criteria for bleeding:

1. Female

2. Age ≥65 years old

3. Hemoglobin≤110g/L

4. Diabetes treated with medications (oral drugs or subcutaneous insulin injections)

5. eGFR<60 ml/min/1.73m2 (MRDR formula)

4. Implant a second-generation drug-eluting stent

5. Intended treatment with dual antiplatelet therapy (aspirin + ticagrelor) after the procedure for at least 12 months

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. Previous drug-related bleeding requiring medications within 12 months;

4. High potential risk of major bleeding, such as acute or chronic gastrointestinal ulcers or other gastrointestinal diseases, malignant tumors, etc.;

5. Previous stroke;

6. Thrombolytic therapy within 24 hours of coronary intervention;

7. Planned surgery within 1 year;

8. Planned coronary revascularization (surgical or percutaneous) within 90 days

9. Allergic to ticagrelor, clopidogrel or aspirin and any excipients;

10. Inability to tolerate 12-month DAPT (ticagrelor+aspirin) for any reason;

11. Cardiogenic shock or hemodynamic instability;

12. Diagnosed as active hepatitis or liver cirrhosis upon admission;

13. Estimated survival time<12 months

14. Suffer from a known serious progressive disease (e.g. progressive cancer, chronic obstructive lung disease, etc.;) or extremely exhausted;

15. Hemoglobin <90g/L;

16. Platelet count<100×109 pcs/L;

17. Dialysis-dependent renal failure；

18. Required use of oral anticoagulation (warfarin or other factor II or factor X inhibitors);

19. Pregnant or plan to be pregnant within 1 year;

20. Any condition that may interfere with any study procedures, such as dementia, immobility, alcohol use, etc;

21. Participating in any other clinical trial of an investigational drug or device that has not met its primary endpoint.