NCT06216821 OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time
| NCT ID | NCT06216821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shenyang Northern Hospital |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,490 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,490 participants in total. It began in 2024-07-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Monotherapy with a P2Y12 inhibitor after a minimum period of DAPT following percutaneous coronary intervention (PCI) is an emerging de-escalation antiplatelet strategy in recent years. However, the optimal timing for de-escalating DAPT in ACS patients undergoing PCI remains debated. The OPT-CAD score is a risk stratification tool derived from Chinese patients which has been demonstrated superior predictive capabilities for ischemic events and all-cause mortality than the GRACE score. Therefore, we hypothesize that the OPT-CAD score can be used to guide the timing of the DAPT de-escalation strategy to monotherapy with P2Y12 inhibitors for ACS patients, that is, low-risk patients could be de-escalated after 1 month, while high-risk patients could be de-escalated after 3 months, so as to achieve individualized antithrombotic therapy and maximize patient benefit.
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.
Contact & Investigator
Yaling Han, PhD
STUDY CHAIR
The General Hospital of Northern Theater Command
Frequently Asked Questions
Who can join the NCT06216821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06216821 currently recruiting?
Yes, NCT06216821 is actively recruiting participants. Contact the research team at doctorliyi@126.com for enrollment information.
Where is the NCT06216821 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06216821 clinical trial?
NCT06216821 is sponsored by Shenyang Northern Hospital. The principal investigator is Yaling Han, PhD at The General Hospital of Northern Theater Command. The trial plans to enroll 3,490 participants.