Sequential use of ticagrelor and clopidogrel after heart procedures

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

This study is testing if switching between two heart medications, ticagrelor and clopidogrel, can help people with acute coronary syndrome after heart procedures while keeping them safe from bleeding.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2690 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04937699 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have been diagnosed with acute coronary syndrome and have received ticagrelor after successful PCI.

Not a fit: Patients with a history of major bleeding risks or those who have received certain types of stents may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer antiplatelet therapy options for patients with acute coronary syndrome, reducing the risk of bleeding complications.

How similar studies have performed: Previous studies have shown promising results with similar de-escalation strategies in antiplatelet therapy, indicating potential for success in this approach.

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.

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Principal investigator: Yong Sun, MD — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Heyang Wang, MD

Conditions Acute Coronary Syndrome; Percutaneous Coronary Intervention; ticagrelor; monotherapy