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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 3490 (estimated) |
| Sponsor | Shenyang Northern Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Status | Recruiting |
| Started | July 2, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT06216821 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
- Study coordinator: Yi Li, PhD
- Email: doctorliyi@126.com
- Phone: +86-24-28897309
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Common femoral vein-to-artery diameter ratio to detect elevated LVEDP
Researchers test whether the ratio of the common femoral vein to artery diameters, measured by ultrasound, can flag elevated LV end-diastolic pressure in patients having coronary angiography.
-
Intrahospital flu vaccine for adults with high cardiovascular risk when admitted for ACS or heart failure
This study tests whether offering a flu vaccine at the bedside during a hospital stay, along with counseling, increases vaccination rates for adults with acute coronary syndrome or heart failure who are at high cardiovascular risk.
-
Digital lifestyle platform after rehabilitation to support self-management
A digital, patient-facing platform is being tested to see if people who recently finished inpatient rehabilitation will use it and benefit from personalized lifestyle guidance at home.
-
AI-driven Medipixel fractional flow reserve to guide PCI
This test checks whether an AI-based, angiography-derived Medipixel FFR method can guide PCI as safely and effectively as standard invasive pressure-wire FFR in adults with coronary artery disease.
-
Freesolve resorbable magnesium scaffold vs. Xience stent for up to two new heart artery lesions
This trial tests whether the Freesolve resorbable magnesium scaffold works as well as the Xience drug-eluting stent for treating up to two new coronary artery lesions in adults.
-
AI-assisted interpretation of chest pain CT in the emergency department
A pragmatic randomized trial tests whether an AI tool (Angiomics) helps emergency physicians interpret coronary CT angiography in adults with acute chest pain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.