Sequential use of ticagrelor and clopidogrel after heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of sequential monotherapy using ticagrelor and clopidogrel in patients with acute coronary syndrome following percutaneous coronary intervention (PCI). Initially, participants will receive standard dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for one month. After this period, event-free subjects will be randomized to either continue DAPT for an additional 12 months or switch to ticagrelor monotherapy for five months, followed by clopidogrel monotherapy for the last six months. The study aims to determine the optimal antiplatelet regimen to minimize bleeding risks while maintaining cardiovascular protection.

Why it matters

Who can join: the full rules

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.

Where it's running

• 2nd Affiliated Hospital, School of Medicine at Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yong Sun, MD — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Heyang Wang, MD
• Email: whysmmu@126.com
• Phone: 86 0571-87783759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.