NCT06216821Recruiting
OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3490 (estimated)
- First submitted
- 11 Jan 2024
- Start date
- 2 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shenyang Northern Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06216821
What you commit to
- Study type: Interventional
- Planned participants: 3490
- From 2 Jul 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated need for revascularization or surgical intervention within 12 months;
Other illness
- Allergy to study drugs such as aspirin, clopidogrel, or ticagrelor;
- Meeting 1 major or 2 minor criteria for high bleeding risk according to the ARC-HBR criteria;
- Severe ischemia or hemorrhage events during the current hospitalization;
- Life expectancy of other serious diseases is less than 1 year;
Age
- Pregnant or women of childbearing age who intend to conceive within 1 year;
Other
- Left main coronary artery lesion PCI;
- Participation in other clinical trials while still under observation;
- Researchers considering ineligibility for enrollment.
Who the study is looking for
- Adult patients with ages of 18-80 years;
- Patients with clinically diagnosed ACS who have undergone at least one DES implantation;
- Individuals capable of completing the OPT-CAD scoring calculation;
- Researchers assessing that participants can tolerate at least a 12-month duration of DAPT therapy;
- Written informed consent provided.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.