OPT-CAD–guided timing for switching to a P2Y12 inhibitor alone after PCI in acute coronary syndrome

OPT-CAD Score Guided Dual Antiplatelet De-escalation Time in Patients With Acute Coronary Syndrome Undergoing Undergoing Percutaneous Coronary Intervention: a Register-based Randomized Controlled Study

This trial will try using the OPT-CAD score to decide whether people with acute coronary syndrome can switch from dual antiplatelet therapy to a single P2Y12 drug after 1 or 3 months following stent placement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3490 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shenyang Northern Hospital (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06216821 on ClinicalTrials.gov

What this trial studies

This interventional trial compares an OPT-CAD score–guided de-escalation strategy to standard dual antiplatelet therapy after percutaneous coronary intervention. Patients classified as low risk by OPT-CAD would be switched to P2Y12 monotherapy after 1 month, while higher-risk patients would switch after 3 months. Eligible participants are adults (18–80) with ACS who received at least one drug-eluting stent and are able to complete OPT-CAD scoring, with several exclusions including high bleeding risk and left main PCI. The main goal is to balance ischemic and bleeding outcomes using a risk-stratified timing approach informed by a score derived in a Chinese population.

Who should consider this trial

Good fit: Adults 18–80 with acute coronary syndrome who received at least one drug-eluting stent, can complete OPT-CAD scoring, and are judged able to tolerate at least 12 months of DAPT at enrollment.

Not a fit: Patients with left main PCI, those meeting ARC-HBR high-bleeding criteria, allergy to aspirin/clopidogrel/ticagrelor, planned revascularization within 12 months, limited life expectancy, or pregnancy plans are unlikely to be eligible or to gain benefit from this protocol.

Why it matters

Potential benefit: If successful, using the OPT-CAD score could help personalize DAPT duration to lower bleeding risk without increasing heart attacks or death.

How similar studies have performed: Prior randomized trials (STOPDAPT-2, SMART-CHOICE, TICO, TWILIGHT) showed earlier P2Y12 monotherapy can reduce bleeding without large ischemic signal, but applying the OPT-CAD score to time de-escalation is a novel approach that requires validation.

Eligibility criteria

Inclusion Criteria:

1. Adult patients with ages of 18-80 years;
2. Patients with clinically diagnosed ACS who have undergone at least one DES implantation;
3. Individuals capable of completing the OPT-CAD scoring calculation;
4. Researchers assessing that participants can tolerate at least a 12-month duration of DAPT therapy;
5. Written informed consent provided.

Exclusion Criteria:

1. Left main coronary artery lesion PCI;
2. Allergy to study drugs such as aspirin, clopidogrel, or ticagrelor;
3. Meeting 1 major or 2 minor criteria for high bleeding risk according to the ARC-HBR criteria;
4. Anticipated need for revascularization or surgical intervention within 12 months;
5. Severe ischemia or hemorrhage events during the current hospitalization;
6. Life expectancy of other serious diseases is less than 1 year;
7. Pregnant or women of childbearing age who intend to conceive within 1 year;
8. Participation in other clinical trials while still under observation;
9. Researchers considering ineligibility for enrollment.

Where this trial is running

Shenyang, Liaoning

• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Yi Li, PhD

Conditions Acute Coronary Syndrome