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NCT Number: NCT07432516

Optimal Antiplatelet and Lipid Therapy in ACS With DES: 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).

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Discontinuation strategy + Combination lipid-lowering therapy

Drug
  • 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 therapy

Drug
  • 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 therapy

Drug
  • 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 therapy

Drug
  • 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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Key Secondray Outcomes for the OPACT-P trial

    Time frame: Withtin 1 and 3 years after enrollement

    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

  2. All-cause death (OPACT-P trial)

    Time frame: Withtin 1 and 3 years after enrollement

    Number of participants who experienced all-cause death during the study period

  3. Cardiovascular death (OPACT-P trial)

    Time frame: Withtin 1 and 3 years after enrollement

    Number of participants who experienced cardiovascular death during the study period

  4. Spontaneous MI (OPACT-P trial)

    Time frame: Withtin 1 and 3 years after enrollement

    Number of participants who experienced spontaneous myocardial infarction during the study period

  5. Stroke (OPACT-P trial)

    Time frame: Withtin 3 years after enrollement

    Number of participants who experienced stroke during the study period

  6. Target-vessel revascularization (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who underwent target-vessel revascularization during the study period

  7. Target-lesion revascularization (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who underwent target-lesion revascularization during the study period

  8. Definite or probable stent thrombosis (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced definite or probable stent thrombosis during the study period

  9. Composite of all-cause death, spontaneous MI, or stroke (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced the composite endpoint of all-cause death, spontaneous MI, or stroke

  10. Composite of cardiovascular death, spontaneous MI, or stent thrombosis (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced the composite endpoint of cardiovascular death, spontaneous MI, or stent thrombosis

  11. Major or clinically relevant non-major bleeding - BARC type 2, 3, 5 (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced major or clinically relevant non-major bleeding as defined by BARC type 2, 3, or 5 criteria

  12. Major or clinically relevant non-major bleeding - ISTH criteria (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced major or clinically relevant non-major bleeding as defined by ISTH criteria

  13. Major or minor bleeding - TIMI criteria (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced major or minor bleeding as defined by TIMI criteria

  14. Moderate, severe, or life-threatening bleeding - GUSTO criteria (OPACT-P trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced moderate, severe, or life-threatening bleeding as defined by GUSTO criteria

  15. Other prespecified analyses for the OPACT-P trial

    Time frame: Withtin 1 and 3 years after enrollement

    A. Type of prescribed antiplatelet therapy B. Rate and reasons for non-adherence to the allocated treatment during study period

  16. All-cause death (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced all-cause death during the study period

  17. Spontaneous MI (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced spontaneous myocardial infarction during the study period

  18. Stroke (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced stroke during the study period

  19. Coronary or peripheral revascularization (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who underwent coronary or peripheral revascularization during the study period

  20. Hospitalization for cardiovascular events (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who required hospitalization for cardiovascular events during the study period

  21. Composite of all-cause death, spontaneous MI, or stroke (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced the composite endpoint of all-cause death, spontaneous MI, or stroke

  22. Composite of all-cause death, spontaneous MI, stent thrombosis, stroke, or TVR (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced the composite endpoint of all-cause death, spontaneous MI, stent thrombosis, stroke, or target-vessel revascularization

  23. Composite of cardiovascular death, spontaneous MI, or TVR (OPACT-L trial)

    Time frame: Within 1 and 3 years after enrollment

    Number of participants who experienced the composite endpoint of cardiovascular death, spontaneous MI, or target-vessel revascularization

  24. Treatment adherence for the OPACT-L trial

    Time frame: Withtin 3 years after enrollement

    Proportion of participants with discontinuation or dose reduction of allocated lipid-lowering therapy during follow-up.

  25. Proportion of patients achieving LDL-C below 55 mg/dL (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Proportion of participants achieving LDL cholesterol levels below 55 mg/dL during the study period

  26. Proportion of patients achieving LDL-C below 70 mg/dL (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Proportion of participants achieving LDL cholesterol levels below 70 mg/dL during the study period

  27. LDL-C variability (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    LDL cholesterol variability (coefficient of variation) during the study period

  28. 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 who experienced HbA1c increase of 0.5% or more from baseline during the study period

  29. Number of participants with CPK greater than 4x ULN (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Number of participants who experienced creatine phosphokinase (CPK) elevation greater than 4 times the upper limit of normal during the study period

  30. Number of participants with AST or ALT 3x or more ULN (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Number of participants who experienced AST and/or ALT elevation of 3 times or more the upper limit of normal during the study period

  31. 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 who experienced serum creatinine increase greater than 50% from baseline during the study period

  32. Number of participants with statin-associated muscle symptom requiring intervention (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Number of participants who experienced statin-associated muscle symptoms requiring intervention (dose reduction, discontinuation, or treatment) during the study period

  33. 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

  34. 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 who underwent target-lesion revascularization during the study period

  35. Number of participants with target-vessel revascularization (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Number of participants who underwent target-vessel revascularization during the study period

  36. Number of participants with new diagnosis of malignancy (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Number of participants who were newly diagnosed with malignancy during the study period

  37. Number of participants with operation due to cataract (OPACT-L trial)

    Time frame: Within 3 years after enrollment

    Number of participants who underwent cataract surgery during the study period

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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