Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

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

Official title: 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

Run by Shenyang Northern Hospital · NCT06216821 · Data updated 2026-11-12

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.

More Acute Coronary Syndrome trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment3490 (estimated)
SponsorShenyang Northern Hospital
Academic / other
Locations1 site (Shenyang, Liaoning)
StatusRecruiting
StartedJuly 2, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedSeptember 10, 2025
Trial IDNCT06216821 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.