OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time (OPT-GUIDNACE)

January 11, 2024 updated by: Yi Li, Shenyang Northern Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3490

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard DAPT therapy
Standard DAPT therapy for 12 mouths
Drug: standard DAPT
standard DAPT with aspirin and a P2Y12 inhibitor for 12 months after DES implantation.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net adverse clinical events (NACE)
Time Frame: 12 months
NACE is defined as a composite of all cause death, myocardial infarction, stroke, stent thrombosis or BARC type 2,3, 5 bleeding
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BARC type 2,3, or 5 bleeding
Time Frame: 3 months and 12 months
3 months and 12 months
BARC type 3 or 5 bleeding
Time Frame: 3 months and 12 months
3 months and 12 months
Major adverse cardiac and cerebral events (MACE)
Time Frame: 3 months and 12 months
MACE is defined as a composite of all cause death, myocardial infarction, stent thrombosis or ischemic stroke
3 months and 12 months
All cause death
Time Frame: 3 months and 12 months
3 months and 12 months
Stent thrombosis
Time Frame: 3 months and 12 months
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Investigators

  • Study Chair: Yaling Han, PhD, The General Hospital of Northern Theater Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT-GUIDANCE V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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