OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time

NCT ID: NCT06216821

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-02
• Study Completion Date: 2027-12-31

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.

Detailed Description

Antiplatelet therapy is a cornerstone of secondary prevention in patients with coronary artery disease. However, as the use of more potent antithrombotic therapy, it not only lowers ischemic risk but increases bleeding. Therefore, fully balancing the risks of thrombosis and bleeding to maximize patient benefit is the basis for antiplatelet therapy. Although there are several scoring systems to assess the risk of thrombotic or bleeding, such as GRACE score, CRUSADE score, PARIS score, and ARC-HBR criteria, the value of the above scoring systems from western populations in guiding dual antiplatelet therapy (DAPT) decisions has not been confirmed. The previous guidelines recommend considering the PRECISE-DAPT score and DAPT score to guide DAPT duration, but their practical application remains limited. The 2020 ESC NSTE-ACS guidelines pointed out that there is still a gap between evidence and practice regarding whether risk-stratified treatment strategies can improve the prognosis of patients, which urgently requires randomized controlled trials (RCTs) for validation.

Monotherapy with a P2Y12 inhibitor after a minimum period of DAPT following percutaneous coronary intervention (PCI) is an emerging de-escalation strategy DAPT in recent years. Previous RCTs such as STOPDAPT-2, SMART-CHOICE, TICO, and TWILIGHT have demonstrated that compared with the conventional 12-month DAPT regimen, de-escalation of DAPT reduced the risk of bleeding without a significant increase in ischaemic events. To be specific, the intervention groups switched to ticagrelor monotherapy after 3 months of DAPT, resulting in comparable ischemic event rates among both TICO trial enrolled ACS patients undergoing PCI and TWILIGHT trial enrolled high-risk patients undergoing PCI. Meanwhile, when STOPDAPT-2 trial enrolled low-risk patients undergoing PCI, the results also indicated that clopidogrel monotherapy after 1 month of DAPT results in similar thrombotic event risks. However, when STOPDAPT-2 ACS trial enrolled ACS patients, compared to the 12-month DAPT group, the results showed that switching from 1- to 2-month DAPT to clopidogrel monotherapy resulted in an increased incidence of myocardial infarction. Given these findings, the optimal timing for de-escalation of DAPT in ACS patients undergoing PCI remain debated.

The Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease (OPT-CAD) score, a risk stratification tool derived from a real-world, multicenter registration study of Chinese patients, has better predictive performance for ischemic events and all-cause mortality at 1-year than those of The Global Acute Coronary Event Registration (GRACE) score. Through the analysis of OPT-CAD population, it was found that low-risk and medium-high risk patients with OPT-CAD scores accounted for about 2/3 and 1/3, respectively, and the risk of major adverse cardiovascular events (MACE) in medium-high risk patients at 1 year follow-up was about 3 times that of low-risk patients. Therefore, we hypothesize that the OPT-CAD score can be used to guide the timing of 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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard DAPT therapy

Standard DAPT therapy for 12 mouths

Group Type: ACTIVE_COMPARATOR

standard DAPT

Intervention Type: DRUG

standard DAPT with aspirin and a P2Y12 inhibitor for 12 months after DES implantation.

OPT-CAD score guided de-escalation DAPT therapy

Patients at moderate to high risk of ischemic events assessed by the OPT-CAD score will receive DAPT therapy for 3 months followed by P2Y12 inhibitor monotherapy for 9 months; Patients at low risk of ischemic events assessed by the OPT-CAD score will receive DAPT for 1 month follow by P2Y12 inhibitor monotherapy for 11 months.

Group Type: EXPERIMENTAL

OPT-CAD score guided DAPT de-escalation

Intervention Type: DRUG

De-escalation DAPT at 3 months for moderate to high risk patients and de-escalation DAPT at 1 month for low risk patients.

Interventions

standard DAPT

standard DAPT with aspirin and a P2Y12 inhibitor for 12 months after DES implantation.

Intervention Type: DRUG

OPT-CAD score guided DAPT de-escalation

De-escalation DAPT at 3 months for moderate to high risk patients and de-escalation DAPT at 1 month for low risk patients.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaling Han, PhD

Role: STUDY_CHAIR

The General Hospital of Northern Theater Command

Locations

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Li, PhD

Role: CONTACT

doctorliyi@126.com

+86-24-28897309

Facility Contacts

Yi Li, MD

Role: primary

doctorliyi@126.com

+86-24-28897309

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Other Identifiers

OPT-GUIDANCE V1.0

Identifier Type: -

Identifier Source: org_study_id