Coronary Artery DiseaseNCT07432516
Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial
A study testing Discontinuation strategy + Combination lipid-lowering therapy, Switching strategy + Combination lipid-lowering therapy and Discontinuation strategy + High-intensity statin therapy in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
" Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) require optimized medical therapy to prevent recurrent cardiovascular events. This includes both antiplatelet and lipid-lowering strategies. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Discontinuation strategy + Combination lipid-lowering therapy, Switching strategy + Combination lipid-lowering therapy and Discontinuation strategy + High-intensity statin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2026to Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19-85 years
- Patients who received DES implantation for treating ACS, including unstable angina, non-ST elevation MI, and ST-elevation MI
- Provision of informed consent
Who cannot join
- Requirement of oral anticoagulant therapy
- Life expectancy <3 years
- Pregnancy or having plan for pregnancy
- Patients with a history of serious adverse events or hypersensitivity to statins
- Patients currently taking drugs that strongly interact with statins (such as cytochrome P-450 3A4 or 2C9 inhibitors)
- Patients with risk factors for myopathy or rhabdomyolysis, such as hereditary muscle disorders, hypothyroidism, alcoholism, and severe liver dysfunction (> 3x UNL)
- Patients who refuse or cannot understand consent to participate in the clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea
Seoul
About this study
Official title: OPtimal Medical Strategy for Patients With Acute Coronary Syndrome Treated With Drug-eluting Stents: Enhancing Outcomes With antiPlatelet and Lipid-lowering Therapy (OPACT Trial)
" Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) require optimized medical therapy to prevent recurrent cardiovascular events. This includes both antiplatelet and lipid-lowering strategies.
For antiplatelet therapy, dual antiplatelet therapy (DAPT) comprising aspirin and a potent P2Y12 inhibitor (such as ticagrelor) for 12 months is the current standard of care. While this regimen is effective in reducing ischemic events, it significantly increases the risk of major bleeding. To mitigate this bleeding risk, DAPT de-escalation strategies have been proposed, including a ""discontinuation strategy"" (early aspirin cessation) and a ""switching strategy"" (switching to a less potent P2Y12 inhibitor). Although previous studies have individually shown the safety and efficacy of these de-escalation approaches compared to standard 12-month DAPT, no head-to-head randomized trial has directly compared the discontinuation strategy (ticagrelor monotherapy after 1 month) against the switching strategy (aspirin plus clopidogrel after 1 month).
Read more
For lipid-lowering therapy, current guidelines recommend high-intensity statin monotherapy to achieve aggressive low-density lipoprotein cholesterol (LDL-C) targets (e.g., < 55 or < 70 mg/dL). However, adherence to high-intensity statins can be limited by concerns over adverse effects and poor patient compliance. In this context, a combination of moderate-intensity statin with ezetimibe has emerged as an alternative. While the previous trials have demonstrated non-inferiority of this combination strategy in a broad population with atherosclerotic cardiovascular disease, its efficacy and safety of initiating a moderate-intensity statin plus ezetimibe combination as the primary lipid-lowering therapy immediately after PCI for ACS remain to be established.
The purpose of this investigation (OPACT trial) is to identify the optimal antiplatelet (OPACT-P) and lipid-lowering (OPACT-L) strategies for patients with ACS following DES implantation.
Read the detailed description
This is a prospective, open-label, multicenter, randomized, 2x2 factorial trial designed to evaluate the optimal antiplatelet and lipid-lowering strategies for patients with ACS following PCI with DES.
Approximately 4,400 patients with ACS who have successfully undergone PCI with DES will be enrolled. Eligible patients will be randomized immediately after the index procedure in a 2x2 factorial design. This design allows for the simultaneous investigation of two separate primary objectives within the OPACT-P (antiplatelet) and OPACT-L (lipid-lowering) trials.
The OPACT-P (antiplatelet) trial will investigate the safety and efficacy of two different DAPT de-escalation strategies. After an initial 1-month period of DAPT with aspirin and ticagrelor, patients will be randomized 1:1 to either:
- A ""Discontinuation Strategy"": Ticagrelor (90 mg twice daily) monotherapy.
- A ""Switching Strategy"": Aspirin (100 mg daily) plus clopidrel (75 mg daily). The primary objective of OPACT-P is to compare the incidence of major or clinically relevant non-major bleeding (defined as BARC type 2, 3, or 5) at 1 year between the two groups. A key secondary endpoint is the composite of major adverse cardiac and cerebrovascular events (MACCE) at 1 and 3 years.
The OPACT-L (lipid-lowering) trial will compare the efficacy and safety of two lipid-lowering strategies, initiated immediately after PCI. Patients will be randomized 1:1 to either:
- Combination Therapy: Moderate-intensity statin (Rosuvastatin 10 mg) plus Ezetimibe (10 mg).
- Monotherapy: High-intensity statin (Rosuvastatin 20 mg). The primary endpoint of OPACT-L is the composite of all-cause death, spontaneous myocardial infarction, stroke, any coronary or peripheral revascularization, and hospitalization due to cardiovascular events at 3 years.
All enrolled patients will be followed for a total of 3 years.
- Conditions
- Coronary Artery Disease
- Being tested
- Discontinuation strategy + Combination lipid-lowering therapy, Switching strategy + Combination lipid-lowering therapy, Discontinuation strategy + High-intensity statin therapy, Switching strategy + High-intensity statin therapy
- Keywords
- percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation strategy + Combination lipid-lowering therapyDrug
- Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid
- Month 1-12: Ticagrelor 90 mg bid (Aspirin discontinued at 1 month)
- Month 0-36: Rosuvastatin 10 mg qd + Ezetimibe 10 mg qd
Switching strategy + Combination lipid-lowering therapyDrug
- Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid
- Month 1-12: Aspirin 100 mg qd + Clopidogrel 75 mg qd (Switched at 1 month)
- Month 0-36: Rosuvastatin 10 mg qd + Ezetimibe 10 mg qd
- Drug : Rosuvastatin 10 mg + Ezetimibe 10 mg
Discontinuation strategy + High-intensity statin therapyDrug
- Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid
- Month 1-12: Ticagrelor 90 mg bid (Aspirin discontinued at 1 month)
- Month 0-36: Rosuvastatin 20 mg qd
Switching strategy + High-intensity statin therapyDrug
- Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid
- Month 1-12: Aspirin 100 mg qd + Clopidogrel 75 mg qd (Switched at 1 month)
- Month 0-36: Rosuvastatin 20 mg qd
- Drug : Rosuvastatin 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor Monotherapy with Moderate-Intensity Statin/Ezetimibe | Experimental | After PCI for ACS with DES, patients start rosuvastatin 10 mg qd + ezetimibe 10 mg qd immediately and continue through 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then discontinue aspirin and continue ticagrelor 90 mg bid through 12 months. Receives: Drug: Discontinuation strategy + Combination lipid-lowering therapy |
| Aspirin + Clopidogrel with Moderate-Intensity Statin/Ezetimibe | Active comparator | After PCI for ACS with DES, patients begin rosuvastatin 10 mg qd + ezetimibe 10 mg qd immediately and continue through 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then switch to aspirin 100 mg qd + clopidogrel 75 mg qd through 12 months. Receives: Drug: Switching strategy + Combination lipid-lowering therapy |
| Ticagrelor Monotherapy with High-Intensity Statin Monotherapy | Active comparator | After PCI for ACS with DES, patients initiate rosuvastatin 20 mg qd immediately and maintain it for up to 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then discontinue aspirin and continue ticagrelor 90 mg bid through 12 months. Receives: Drug: Discontinuation strategy + High-intensity statin therapy |
| Aspirin + Clopidogrel with High-Intensity Statin Monotherapy | Active comparator | After PCI for ACS with DES, patients initiate rosuvastatin 20 mg qd immediately and maintain it for up to 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then switch to aspirin 100 mg qd + clopidogrel 75 mg qd through 12 months. Receives: Drug: Switching strategy + High-intensity statin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major or Clinically-Relevant Non-Major Bleeding (OPACT-P)
Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding
Measured: Within 1 year after enrollment
Major Adverse Cardiac Events (OPACT-L)
A composite of all-cause death, spontaneous MI, stroke, coronary or peripheral revascularization, and hospitalization for cardiovascular events
Measured: Within 3 years after enrollment
Secondary outcomes (37)
Key Secondray Outcomes for the OPACT-P trial
AA. MACCE (composite of all-cause death, spontaneous MI, stent thrombosis, stroke, or target-vessel revascularization) B. NACE: Major or clinically relevant non-major bleeding (BARC type 2, 3, 5) and MACCE C. BARC type 2 bleeding D. BARC type 3 bleeding E. BARC type 5 bleeding
Measured: Withtin 1 and 3 years after enrollement
All-cause death (OPACT-P trial)
Number of participants who experienced all-cause death during the study period
Measured: Withtin 1 and 3 years after enrollement
Cardiovascular death (OPACT-P trial)
Number of participants who experienced cardiovascular death during the study period
Measured: Withtin 1 and 3 years after enrollement
Spontaneous MI (OPACT-P trial)
Number of participants who experienced spontaneous myocardial infarction during the study period
Measured: Withtin 1 and 3 years after enrollement
Stroke (OPACT-P trial)
Number of participants who experienced stroke during the study period
Measured: Withtin 3 years after enrollement
Target-vessel revascularization (OPACT-P trial)
Number of participants who underwent target-vessel revascularization during the study period
Measured: Within 1 and 3 years after enrollment
Target-lesion revascularization (OPACT-P trial)
Number of participants who underwent target-lesion revascularization during the study period
Measured: Within 1 and 3 years after enrollment
Definite or probable stent thrombosis (OPACT-P trial)
Number of participants who experienced definite or probable stent thrombosis during the study period
Measured: Within 1 and 3 years after enrollment
Composite of all-cause death, spontaneous MI, or stroke (OPACT-P trial)
Number of participants who experienced the composite endpoint of all-cause death, spontaneous MI, or stroke
Measured: Within 1 and 3 years after enrollment
Composite of cardiovascular death, spontaneous MI, or stent thrombosis (OPACT-P trial)
Number of participants who experienced the composite endpoint of cardiovascular death, spontaneous MI, or stent thrombosis
Measured: Within 1 and 3 years after enrollment
Major or clinically relevant non-major bleeding - BARC type 2, 3, 5 (OPACT-P trial)
Number of participants who experienced major or clinically relevant non-major bleeding as defined by BARC type 2, 3, or 5 criteria
Measured: Within 1 and 3 years after enrollment
Major or clinically relevant non-major bleeding - ISTH criteria (OPACT-P trial)
Number of participants who experienced major or clinically relevant non-major bleeding as defined by ISTH criteria
Measured: Within 1 and 3 years after enrollment
Major or minor bleeding - TIMI criteria (OPACT-P trial)
Number of participants who experienced major or minor bleeding as defined by TIMI criteria
Measured: Within 1 and 3 years after enrollment
Moderate, severe, or life-threatening bleeding - GUSTO criteria (OPACT-P trial)
Number of participants who experienced moderate, severe, or life-threatening bleeding as defined by GUSTO criteria
Measured: Within 1 and 3 years after enrollment
Other prespecified analyses for the OPACT-P trial
- Type of prescribed antiplatelet therapy B. Rate and reasons for non-adherence to the allocated treatment during study period
Measured: Withtin 1 and 3 years after enrollement
All-cause death (OPACT-L trial)
Number of participants who experienced all-cause death during the study period
Measured: Within 1 and 3 years after enrollment
Spontaneous MI (OPACT-L trial)
Number of participants who experienced spontaneous myocardial infarction during the study period
Measured: Within 1 and 3 years after enrollment
Stroke (OPACT-L trial)
Number of participants who experienced stroke during the study period
Measured: Within 1 and 3 years after enrollment
Coronary or peripheral revascularization (OPACT-L trial)
Number of participants who underwent coronary or peripheral revascularization during the study period
Measured: Within 1 and 3 years after enrollment
Hospitalization for cardiovascular events (OPACT-L trial)
Number of participants who required hospitalization for cardiovascular events during the study period
Measured: Within 1 and 3 years after enrollment
Composite of all-cause death, spontaneous MI, or stroke (OPACT-L trial)
Number of participants who experienced the composite endpoint of all-cause death, spontaneous MI, or stroke
Measured: Within 1 and 3 years after enrollment
Composite of all-cause death, spontaneous MI, stent thrombosis, stroke, or TVR (OPACT-L trial)
Number of participants who experienced the composite endpoint of all-cause death, spontaneous MI, stent thrombosis, stroke, or target-vessel revascularization
Measured: Within 1 and 3 years after enrollment
Composite of cardiovascular death, spontaneous MI, or TVR (OPACT-L trial)
Number of participants who experienced the composite endpoint of cardiovascular death, spontaneous MI, or target-vessel revascularization
Measured: Within 1 and 3 years after enrollment
Treatment adherence for the OPACT-L trial
Proportion of participants with discontinuation or dose reduction of allocated lipid-lowering therapy during follow-up.
Measured: Withtin 3 years after enrollement
Proportion of patients achieving LDL-C below 55 mg/dL (OPACT-L trial)
Proportion of participants achieving LDL cholesterol levels below 55 mg/dL during the study period
Measured: Within 3 years after enrollment
Proportion of patients achieving LDL-C below 70 mg/dL (OPACT-L trial)
Proportion of participants achieving LDL cholesterol levels below 70 mg/dL during the study period
Measured: Within 3 years after enrollment
LDL-C variability (OPACT-L trial)
LDL cholesterol variability (coefficient of variation) during the study period
Measured: Within 3 years after enrollment
Number of participants with HbA1c increase 0.5% or more from baseline (OPACT-L trial)
Number of participants who experienced HbA1c increase of 0.5% or more from baseline during the study period
Measured: Within 3 years after enrollment
Number of participants with CPK greater than 4x ULN (OPACT-L trial)
Number of participants who experienced creatine phosphokinase (CPK) elevation greater than 4 times the upper limit of normal during the study period
Measured: Within 3 years after enrollment
Number of participants with AST or ALT 3x or more ULN (OPACT-L trial)
Number of participants who experienced AST and/or ALT elevation of 3 times or more the upper limit of normal during the study period
Measured: Within 3 years after enrollment
Number of participants with serum creatinine increase greater than 50% from baseline (OPACT-L trial)
Number of participants who experienced serum creatinine increase greater than 50% from baseline during the study period
Measured: Within 3 years after enrollment
Number of participants with statin-associated muscle symptom requiring intervention (OPACT-L trial)
Number of participants who experienced statin-associated muscle symptoms requiring intervention (dose reduction, discontinuation, or treatment) during the study period
Measured: Within 3 years after enrollment
Number of participants with new-onset diabetes or diabetes requiring new medication (OPACT-L trial)
Number of participants who developed new-onset diabetes or required new anti-diabetic medication during the study period
Measured: Within 3 years after enrollment
Number of participants who developed new-onset diabetes or required new anti-diabetic medication during the study period
Number of participants who underwent target-lesion revascularization during the study period
Measured: Within 3 years after enrollment
Number of participants with target-vessel revascularization (OPACT-L trial)
Number of participants who underwent target-vessel revascularization during the study period
Measured: Within 3 years after enrollment
Number of participants with new diagnosis of malignancy (OPACT-L trial)
Number of participants who were newly diagnosed with malignancy during the study period
Measured: Within 3 years after enrollment
Number of participants with operation due to cataract (OPACT-L trial)
Number of participants who underwent cataract surgery during the study period
Measured: Within 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2033 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432516
- Sponsor's protocol ID
- 4-2025-0558
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal Medical Strategy for Patients With Acute Coronary Syndrome Treated With Drug-eluting Stents: Enhancing Outcomes With antiPlatelet and Lipid-lowering Therapy (OPACT Trial)
- ClinicalTrials.gov ID
- NCT07432516
- Acronym / sponsor ID
- 4-2025-0558
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
" Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) require optimized medical therapy to prevent recurrent cardiovascular events. This includes both antiplatelet and lipid-lowering strategies.
For antiplatelet therapy, dual antiplatelet therapy (DAPT) comprising aspirin and a potent P2Y12 inhibitor (such as ticagrelor) for 12 months is the current standard of care. While this regimen is effective in reducing ischemic events, it significantly increases the risk of major bleeding. To mitigate this bleeding risk, DAPT de-escalation strategies have been proposed, including a ""discontinuation strategy"" (early aspirin cessation) and a ""switching strategy"" (switching to a less potent P2Y12 inhibitor). Although previous studies have individually shown the safety and efficacy of these de-escalation approaches compared to standard 12-month DAPT, no head-to-head randomized trial has directly compared the discontinuation strategy (ticagrelor monotherapy after 1 month) against the switching strategy (aspirin plus clopidogrel after 1 month).
For lipid-lowering therapy, current guidelines recommend high-intensity statin monotherapy to achieve aggressive low-density lipoprotein cholesterol (LDL-C) targets (e.g., < 55 or < 70 mg/dL). However, adherence to high-intensity statins can be limited by concerns over adverse effects and poor patient compliance. In this context, a combination of moderate-intensity statin with ezetimibe has emerged as an alternative. While the previous trials have demonstrated non-inferiority of this combination strategy in a broad population with atherosclerotic cardiovascular disease, its efficacy and safety of initiating a moderate-intensity statin plus ezetimibe combination as the primary lipid-lowering therapy immediately after PCI for ACS remain to be established.
The purpose of this investigation (OPACT trial) is to identify the optimal antiplatelet (OPACT-P) and lipid-lowering (OPACT-L) strategies for patients with ACS following DES implantation.
Detailed description
This is a prospective, open-label, multicenter, randomized, 2x2 factorial trial designed to evaluate the optimal antiplatelet and lipid-lowering strategies for patients with ACS following PCI with DES.
Approximately 4,400 patients with ACS who have successfully undergone PCI with DES will be enrolled. Eligible patients will be randomized immediately after the index procedure in a 2x2 factorial design. This design allows for the simultaneous investigation of two separate primary objectives within the OPACT-P (antiplatelet) and OPACT-L (lipid-lowering) trials.
The OPACT-P (antiplatelet) trial will investigate the safety and efficacy of two different DAPT de-escalation strategies. After an initial 1-month period of DAPT with aspirin and ticagrelor, patients will be randomized 1:1 to either:
- A ""Discontinuation Strategy"": Ticagrelor (90 mg twice daily) monotherapy.
- A ""Switching Strategy"": Aspirin (100 mg daily) plus clopidrel (75 mg daily). The primary objective of OPACT-P is to compare the incidence of major or clinically relevant non-major bleeding (defined as BARC type 2, 3, or 5) at 1 year between the two groups. A key secondary endpoint is the composite of major adverse cardiac and cerebrovascular events (MACCE) at 1 and 3 years.
The OPACT-L (lipid-lowering) trial will compare the efficacy and safety of two lipid-lowering strategies, initiated immediately after PCI. Patients will be randomized 1:1 to either:
- Combination Therapy: Moderate-intensity statin (Rosuvastatin 10 mg) plus Ezetimibe (10 mg).
- Monotherapy: High-intensity statin (Rosuvastatin 20 mg). The primary endpoint of OPACT-L is the composite of all-cause death, spontaneous myocardial infarction, stroke, any coronary or peripheral revascularization, and hospitalization due to cardiovascular events at 3 years.
All enrolled patients will be followed for a total of 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor Monotherapy with Moderate-Intensity Statin/Ezetimibe | Experimental | Drug: Discontinuation strategy + Combination lipid-lowering therapyAfter PCI for ACS with DES, patients start rosuvastatin 10 mg qd + ezetimibe 10 mg qd immediately and continue through 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then discontinue aspirin and continue ticagrelor 90 mg bid through 12 months. |
| Aspirin + Clopidogrel with Moderate-Intensity Statin/Ezetimibe | Active comparator | Drug: Switching strategy + Combination lipid-lowering therapyAfter PCI for ACS with DES, patients begin rosuvastatin 10 mg qd + ezetimibe 10 mg qd immediately and continue through 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then switch to aspirin 100 mg qd + clopidogrel 75 mg qd through 12 months. |
| Ticagrelor Monotherapy with High-Intensity Statin Monotherapy | Active comparator | Drug: Discontinuation strategy + High-intensity statin therapyAfter PCI for ACS with DES, patients initiate rosuvastatin 20 mg qd immediately and maintain it for up to 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then discontinue aspirin and continue ticagrelor 90 mg bid through 12 months. |
| Aspirin + Clopidogrel with High-Intensity Statin Monotherapy | Active comparator | Drug: Switching strategy + High-intensity statin therapyAfter PCI for ACS with DES, patients initiate rosuvastatin 20 mg qd immediately and maintain it for up to 36 months. They receive aspirin 100 mg qd + ticagrelor 90 mg bid for 1 month, then switch to aspirin 100 mg qd + clopidogrel 75 mg qd through 12 months. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 19-85 years
- Patients who received DES implantation for treating ACS, including unstable angina, non-ST elevation MI, and ST-elevation MI
- Provision of informed consent
Key exclusion criteria (7 listed)
- Requirement of oral anticoagulant therapy
- Life expectancy <3 years
- Pregnancy or having plan for pregnancy
- Patients with a history of serious adverse events or hypersensitivity to statins
- Patients currently taking drugs that strongly interact with statins (such as cytochrome P-450 3A4 or 2C9 inhibitors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation strategy + Combination lipid-lowering therapy* Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid * Month 1-12: Ticagrelor 90 mg bid (Aspirin discontinued at 1 month) * Month 0-36: Rosuvastatin 10 mg qd + Ezetimibe 10 mg qd | Drug | Ticagrelor Monotherapy with Moderate-Intensity Statin/Ezetimibe |
| Switching strategy + Combination lipid-lowering therapy* Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid * Month 1-12: Aspirin 100 mg qd + Clopidogrel 75 mg qd (Switched at 1 month) * Month 0-36: Rosuvastatin 10 mg qd + Ezetimibe 10 mg qd * Drug : Rosuvastatin 10 mg + Ezetimibe 10 mg | Drug | Aspirin + Clopidogrel with Moderate-Intensity Statin/Ezetimibe |
| Discontinuation strategy + High-intensity statin therapy* Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid * Month 1-12: Ticagrelor 90 mg bid (Aspirin discontinued at 1 month) * Month 0-36: Rosuvastatin 20 mg qd | Drug | Ticagrelor Monotherapy with High-Intensity Statin Monotherapy |
| Switching strategy + High-intensity statin therapy* Month 0-1: Aspirin 100 mg qd + Ticagrelor 90 mg bid * Month 1-12: Aspirin 100 mg qd + Clopidogrel 75 mg qd (Switched at 1 month) * Month 0-36: Rosuvastatin 20 mg qd * Drug : Rosuvastatin 20 mg | Drug | Aspirin + Clopidogrel with High-Intensity Statin Monotherapy |
Primary outcome
Major or Clinically-Relevant Non-Major Bleeding (OPACT-P)
Time frame: Within 1 year after enrollment
Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding
Major Adverse Cardiac Events (OPACT-L)
Time frame: Within 3 years after enrollment
A composite of all-cause death, spontaneous MI, stroke, coronary or peripheral revascularization, and hospitalization for cardiovascular events
37 secondary outcomes
Key Secondray Outcomes for the OPACT-P trial
Time frame: Withtin 1 and 3 years after enrollement
All-cause death (OPACT-P trial)
Time frame: Withtin 1 and 3 years after enrollement
Cardiovascular death (OPACT-P trial)
Time frame: Withtin 1 and 3 years after enrollement
Spontaneous MI (OPACT-P trial)
Time frame: Withtin 1 and 3 years after enrollement
Stroke (OPACT-P trial)
Time frame: Withtin 3 years after enrollement
Target-vessel revascularization (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Target-lesion revascularization (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Definite or probable stent thrombosis (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Composite of all-cause death, spontaneous MI, or stroke (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Composite of cardiovascular death, spontaneous MI, or stent thrombosis (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Major or clinically relevant non-major bleeding - BARC type 2, 3, 5 (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Major or clinically relevant non-major bleeding - ISTH criteria (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Major or minor bleeding - TIMI criteria (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Moderate, severe, or life-threatening bleeding - GUSTO criteria (OPACT-P trial)
Time frame: Within 1 and 3 years after enrollment
Other prespecified analyses for the OPACT-P trial
Time frame: Withtin 1 and 3 years after enrollement
All-cause death (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Spontaneous MI (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Stroke (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Coronary or peripheral revascularization (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Hospitalization for cardiovascular events (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Composite of all-cause death, spontaneous MI, or stroke (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Composite of all-cause death, spontaneous MI, stent thrombosis, stroke, or TVR (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Composite of cardiovascular death, spontaneous MI, or TVR (OPACT-L trial)
Time frame: Within 1 and 3 years after enrollment
Treatment adherence for the OPACT-L trial
Time frame: Withtin 3 years after enrollement
Proportion of patients achieving LDL-C below 55 mg/dL (OPACT-L trial)
Time frame: Within 3 years after enrollment
Proportion of patients achieving LDL-C below 70 mg/dL (OPACT-L trial)
Time frame: Within 3 years after enrollment
LDL-C variability (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with HbA1c increase 0.5% or more from baseline (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with CPK greater than 4x ULN (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with AST or ALT 3x or more ULN (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with serum creatinine increase greater than 50% from baseline (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with statin-associated muscle symptom requiring intervention (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with new-onset diabetes or diabetes requiring new medication (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants who developed new-onset diabetes or required new anti-diabetic medication during the study period
Time frame: Within 3 years after enrollment
Number of participants with target-vessel revascularization (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with new diagnosis of malignancy (OPACT-L trial)
Time frame: Within 3 years after enrollment
Number of participants with operation due to cataract (OPACT-L trial)
Time frame: Within 3 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation strategy + Combination lipid-lowering therapy, Switching strategy + Combination lipid-lowering therapy and Discontinuation strategy + High-intensity statin therapy in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major or Clinically-Relevant Non-Major Bleeding (OPACT-P) (time frame: Within 1 year after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.