Comparing 1 Month vs. 12 Months of Dual Antiplatelet Therapy after Heart Procedures
Prospective, Open-label, Multicenter, Randomized Clinical Trial Comparing 1 Month vs. 12 Months Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention With Genoss® Drug Eluting Stent
This study is testing if taking dual antiplatelet therapy for just one month instead of twelve months after heart procedures can help patients avoid bleeding risks without causing more heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2186 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul St. Mary's Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05770674 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of one month of dual antiplatelet therapy (DAPT) using aspirin and clopidogrel, followed by clopidogrel monotherapy, against a standard twelve-month DAPT regimen in patients undergoing percutaneous coronary intervention (PCI) with Genoss® drug-eluting stents. The study aims to determine if a shorter duration of DAPT can reduce the risk of bleeding without increasing the risk of ischemic events. It is a multicenter, randomized, open-label trial designed to provide insights into optimal antiplatelet therapy duration for patients with coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who are undergoing elective PCI with Genoss® drug-eluting stents.
Not a fit: Patients with acute myocardial infarction, those requiring anticoagulation, or individuals with a history of intracranial hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatment protocols for patients undergoing PCI, minimizing bleeding risks while maintaining cardiovascular protection.
How similar studies have performed: Previous studies have indicated that shorter durations of DAPT may be effective, suggesting this approach could be promising but still requires further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be at least 19 years of age * Subjects undergoing elective PCI with Genoss® Drug Eluting Stents * Subject who can understand the risk, benefit and treatment alternatives, and when he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure Exclusion Criteria: * Subjects presenting with acute myocardial infarction * Subjects with less than 1 year of life expectancy * Subjects presenting with cardiogenic shock * Subjects requiring anticoagulation (warfarin, direct oral anticoagulant), or those requiring antiplatelet agents other than aspirin and P2Y12 inhibitors. * Subjects with history of intracranial hemorrhage (ICH) * Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel), or drugs used in the procedure (heparin, contrast media, sirolimus). Those with contrast hypersensitivity can be enrolled if symptom/signs can be controlled by anti-histamines or steroids.
Where this trial is running
Seoul
- Seoul St. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Kiyuk Chang — Seoul St. Mary's Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.