One-Month Dual Antiplatelet Therapy followed by P2Y12 Inhibitor Monotherapy After Biofreedom Ultra® Stent Implantation in Patients with Acute Coronary Syndrome: DAPT-FREE TRIA
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006530
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1
1) Adults 19 years of age or older
2) Acute coronary patients who had successful percutaneous coronary intervention (PCI) with Biofreedom Ultra® stent
3) Subjects who agree to the research protocol and clinical follow-up plan, decide voluntarily to participate in this clinical study, and agree in writing to the subject consent form
1) Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, sirolimus, contrast agent
2) If you are taking anticoagulants: warfarin, apixaban, rivaroxaban, dabigatran, edoxaban
3) In case of previous myocardial infarction or coronary artery resection (percutaneous coronary intervention or coronary artery bypass surgery)
4) Subjects with transient ischemic attack (TIA) or stroke
5) Subjects of fertile age who are planning to become pregnant or cannot rule out pregnancy during the study period
6) Subjects whose remaining life expectancy is less than 1 year
7) Subjects who visited the hospital due to cardiac arrest or psychogenic shock and whose survival is predicted to be low by medical judgment
8) Complex lesions – unprotected left main lesions, chronic obstructive lesions, severely calcified or tortuous lesions
9) You are participating in another randomized controlled study, or you are participating in an observational study that may affect the study.
10) In case the researcher judges that it is not suitable for this clinical study or may increase the risk related to research participation
11) Patients with severe renal and hepatic dysfunction including hemodialysis patients and cirrhosis patients
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Variables used for evaluation are used by collecting test data and clinical progress items made during the patient's normal treatment after PCI. In addition to the above items, blood tests and electrocardiogram tests performed during the treatment process are collected and analyzed.
- Secondary Outcome Measures
Name Time Method net adverse clinical events): a composite of cardiac death, nonfatal myocardial Infarction, ischemia-driven target vessel revascularization, stroke, or major bleeding (BARC criteria 3)