Yonsei University Health System, Severance Hospital
Seoul, South Korea
Location status: Recruiting
NCT Number: NCT05320926
Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.
Interested in participating?
Request Info19 year–84 year
All sexes
Interventional
Not applicable
Seoul, South Korea
Location status: Recruiting
The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.
Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.
zotarolimus-eluting stent (Resolute Onyx ®)
Time frame: 1 year after the procedure
Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)
Time frame: 1 year after the procedure
Time frame: 1 year after the procedure
Time frame: 1 year after the procedure
Time frame: 1 year after the procedure
Time frame: 1 year after the procedure
Time frame: 1 year after the procedure
Contact information is provided by the study sponsor or research team.
Yonsei University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07081711
Aortic Diseases, Arrhythmias, Cardiac
Cleveland, Ohio, United States
View Trial DetailsNCT07091682
Acute Coronary Syndrome, Acute Coronary Syndromes
Erfurt, Germany
View Trial DetailsNCT07635407
Arterial Occlusive Diseases, Arteriosclerosis
Beijing, Beijing Municipality, China
View Trial DetailsNCT07399002
Arterial Occlusive Diseases, Arteriosclerosis
Cabueñes, Spain
View Trial Details