Phase None Recruiting NCT06216821

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

Shenyang Northern Hospital · Interventional, Randomized · n=3,490

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Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT06216821).

Eligibility

Age range: 18–80 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase
Phase None
Study type
Interventional
Allocation
Randomized
Masking
Single-blind
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment target
3,490 participants
Started
July 2024
Estimated completion
December 2027

Outcome measures

Locations & contactsi

Filter by location Showing 1 of 1 sites

1 site currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

General Hospital of Northern Theater Command — Shenyang, Liaoning (China)

Sources

REG
ClinicalTrials.gov — NCT06216821
Trial registry · primary record
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