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OCT or Angiography Guided De-escalation of DAPT

NCT06339021 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-01

No results posted yet for this study

Summary

Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.

Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation.

Conditions

  • Optical Coherence Tomography
  • Dual Antiplatelet Therapy
  • Antiplatelet De-escalation
  • Neointimal Coverage
  • ST Elevation Myocardial Infarction

Interventions

PROCEDURE

OCT-guided PCI

OCT-guided PCI based on MLD MAX algorithm

PROCEDURE

Conventional angiography-based PCI

Conventional angiography-based PCI

DRUG

DAPT de-escalation

Aspirin and clopidogrel 30 days after DES implantation

DRUG

default DAPT regimen

Aspirin and ticagrelor 30 days after DES implantation

Sponsors & Collaborators

  • Shenyang Northern Hospital

    lead OTHER

Principal Investigators

  • Yaling Han · Shenyang Northern Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06339021 on ClinicalTrials.gov