None listed
Conditions
Interventions
Drug : Among patients with acute coronary syndrome (ACS) treated with drug-eluting stent (DES) implantation, the OPACT-P study will compare two groups: one group will receive dual antiplatelet therap
the other group will receive the same initial 1-month DAPT with aspirin 100 mg once daily and ticagrelor 90 mg twice daily, followed by a switch to aspirin 100 mg once daily and clopidogrel 75 mg once
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 19–85 years 2. Patients who received DES implantation for treating ACS, including unstable angina, non-ST elevation MI, and ST-elevation MI 3. If prior consent has been given
Exclusion criteria
Exclusion criteria: 1. Requirement of oral anticoagulant therapy 2. Life expectancy 3x UNL) 9. Patients who refuse or cannot understand consent to participate in the clinical trial 10. Patients with sever heart failure (left ventricular ejection fraction <30%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major or clinically relevant non-major bleeding (BARC type 2, 3, 5) at 1 years for the OPACT-P study;Composite of all-cause death at 3 years for the OPACT-L study;spontaneous MI at 3 years for the OPACT-L study;stroke at 3 years for the OPACT-L study;coronary or peripheral revascularization, and hospitalization for cardiovascular events at 3 years for the OPACT-L study | — |
Secondary
| Measure | Time frame |
|---|---|
| MACCE (composite of all death, spontaneous MI, stent thrombosis, stroke, or target-vessel revascularization) at 1 and 3 years;NACE; Major or clinically relevant non-major bleeding (BARC type 2, 3, 5) and MACCE (composite of all death, spontaneous MI, stent thrombosis, stroke, or target-vessel revascularization) at 1 and 3 years ;Bleeding Academic Research Consortium (BARC) type 2 bleeding at 1 and 3 years ;Bleeding Academic Research Consortium (BARC) type 3 bleeding at 1 and 3 years ;Bleeding Academic Research Consortium (BARC) type 5 bleeding at 1 and 3 years ;All-cause death at 1 and 3 years ;Cardiovascular death at 1 and 3 years ;Spontaneous MI at 1 and 3 years ;Stroke at 1 and 3 years ;Target-vessel revascularization at 1 and 3 years ;Target-lesion revascularization at 1 and 3 years ;Definite or probable stent thrombosis at 1 and 3 years ;Type of prescribed antiplatelet therapy at 2 years, and 3 years;The composite of all-cause death, spontaneous MI, or stroke at 1 and 3 years ;The composite of cardiovascular death, spontaneous MI, or stent thrombosis at 1 and 3 years ;Major or clinically relevant non-major bleeding (BARC type 2, 3, 5) at 3 years;Major or clinically relevant non-major bleeding (ISTH criteria) at 3 years ;Major or minor bleeding (TIMI criteria) at 3 years ;Moderate, severe, or life-threatening bleeding (GUSTO criteria) at 3 years;Rate and reasons for non-adherence to the allocated treatment during study period;Hospitalization for cardiovascular events at 1 and 3 years;Coronary revascularization at 1 and 3 years;Peripheral revascularization at 1 and 3 years; stent thrombosis, target-vessel revascularization at 1 and 3 years;Discontinuation or dose reduction of allocated lipid-lowering therapy during study period;Rate and reasons for non-adherence to the allocated treatment during study period;Proportion of patients achieving LDL cholesterol levels 4 x UNL);Elevation of hepatic enzyme (AST, ALT, or both = 3 x UNL);Elevation of serum creatinine lev | — |
Countries
Korea, Republic of
Contacts
Public ContactByeong-Keuk kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed