Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial

NCT07432516 | Not Yet Recruiting DMC

• 1 other identifier: 4-2025-0558
• Study Type: interventional
• Target: 4,400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• Major or Clinically-Relevant Non-Major Bleeding (OPACT-P)

  Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding

  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

  Within 3 years after enrollment

Secondary Outcomes (37)

• Key Secondray Outcomes for the OPACT-P trial

  Withtin 1 and 3 years after enrollement

• All-cause death (OPACT-P trial)

  Withtin 1 and 3 years after enrollement

• Cardiovascular death (OPACT-P trial)

  Withtin 1 and 3 years after enrollement

• Spontaneous MI (OPACT-P trial)

  Withtin 1 and 3 years after enrollement

• Stroke (OPACT-P trial)

  Withtin 3 years after enrollement

Study Arms (4)

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.

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.

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.

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.

Drug: Switching strategy + High-intensity statin therapy

Interventions

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

Ticagrelor Monotherapy with Moderate-Intensity Statin/Ezetimibe

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

Aspirin + Clopidogrel with Moderate-Intensity Statin/Ezetimibe

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

Ticagrelor Monotherapy with High-Intensity Statin Monotherapy

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

Aspirin + Clopidogrel with High-Intensity Statin Monotherapy

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)