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OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time

ConditionAcute Coronary Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenyang Northern Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Left main coronary artery lesion PCI;

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;

Anticipated need for revascularization or surgical intervention within 12 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • standard DAPT

    Drug

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

  • OPT-CAD score guided DAPT de-escalation

    Drug

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

Treatment groups

3,490 Participants
are divided into 2 treatment groups
Group A: Standard DAPT therapyActive comparator 1 intervention
Group B: OPT-CAD score guided de-escalation DAPT therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Net adverse clinical events (NACE)

NACE is defined as a composite of all cause death, myocardial infarction, stroke, stent thrombosis or BARC type 2,3, 5 bleeding

Time frame
12 months

Secondary outcomes

1

BARC type 2,3, or 5 bleeding

Time frame
3 months and 12 months
2

BARC type 3 or 5 bleeding

Time frame
3 months and 12 months
3

Major adverse cardiac and cerebral events (MACE)

MACE is defined as a composite of all cause death, myocardial infarction, stent thrombosis or ischemic stroke

Time frame
3 months and 12 months
4

All cause death

Time frame
3 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Northern Hospital

Lead sponsor

Source ClinicalTrials.gov
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