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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
General Hospital of Northern Theater Command
RECRUITING
Shenyang
Contact Information
Primary
Yi Li, PhD
doctorliyi@126.com
+86-24-28897309
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 3490
Treatments
Active_comparator: Standard DAPT therapy
Standard DAPT therapy for 12 mouths
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.
Sponsors
Leads: Shenyang Northern Hospital

This content was sourced from clinicaltrials.gov

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