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One-Month Dual Antiplatelet Therapy followed by P2Y12 Inhibitor Monotherapy After Biofreedom Ultra® Stent Implantation in Patients with Acute Coronary Syndrome: DAPT-FREE TRIAL

One-Month Dual Antiplatelet Therapy followed by P2Y12 Inhibitor Monotherapy After Biofreedom Ultra® Stent Implantation in Patients with Acute Coronary Syndrome: DAPT-FREE TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006530
Enrollment
1
Registered
2021-09-02
Start date
2021-07-26
Completion date
Unknown
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others( Acute coronary patients undergoing percutaneous coronary intervention (PCI) with Biofreedom Ultra® stent) : After PCI, patients receive a maintenance dose (MD) of aspirin 100mg and a P2Y12 inh

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
net adverse clinical events): a composite of cardiac death, nonfatal myocardial Infarction, ischemia-driven target vessel revascularization, stroke, or major bleeding (BARC criteria 3)

Countries

Korea, Republic of

Contacts

Public Contactminji kim

Chonnam National University Hospital

minkky12@daum.net+82-62-220-6572

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026