Acute Coronary Syndrome
Conditions
Keywords
Acute coronary syndrome, Drug-eluting stent, Dual-antiplatelet therapy, Ticagrelor
Brief summary
To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.
Detailed description
This trial is an open-label, randomized, multi-center study. Patients with ACS requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of DCS group or DES group. After the index procedure, DAPT (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. After this, ticagrelor monotherapy will be maintained for 11 months. Clinical events will be evaluated within 12 months after randomization.
Interventions
DEVICEDrug-coated stent
The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.
DEVICEDrug-eluting stent
The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥19 years 2. All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome 3. Provision of informed consent
Exclusion criteria
1. Current or potential pregnancy 2. Need of oral anticoagulation therapy 3. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Oriented Composite Endpoint (POCE) | At 1 year after randomization | The composite of all-cause death, MI, or any revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target-lesion revascularization | At 1 year after randomization | Clinically indicated or ischemia driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion |
| BARC type 2-5 bleeding | At 1 year after randomization | According to a consensus report from the Bleeding Academic Research Consortium |
| Device-Oriented Composite Endpoint (DOCE) | At 1 year after randomization | The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR) |
| All-cause death | At 1 year after randomization | All death including cardiovascular death |
| Cardiovascular death | At 1 year after randomization | Death resulting from cardiovascular causes or undetermined cause of death not attributable to any other category because of the absence of any relevant source documents |
| BARC type 3-5 bleeding | At 1 year after randomization | According to a consensus report from the Bleeding Academic Research Consortium |
| Stroke | At 1 year after randomization | Loss of neurologic function caused by an ischemic or hemorrhagic event |
| Stent thrombosis (definite or probable) | At 1 year after randomization | By the Academic Research Consortium-2 Consensus Document |
| Any revascularization | At 1 year after randomization | All revascularizations including target-vessel revascularization and and non-target-vessel revascularization |
| Target-vessel revascularization | At 1 year after randomization | Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion |
| Non-target vessel revascularization | At 1 year after randomization | Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel |
| Myocardial infarction | At 1 year after randomization | A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document |
Countries
South Korea
Contacts
Primary ContactChul-Min Ahn
Backup ContactSung-Jin Hong, MD, PhD
Outcome results
None listed