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NOT YET RECRUITING
NCT06339021
EARLY_PHASE1

OCT or Angiography Guided De-escalation of DAPT

Sponsor: Shenyang Northern Hospital

View on ClinicalTrials.gov

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.

Official title: Evaluation of Neointimal Coverage After Guiding De-escalation of Antiplatelet Treatment in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention by Optical Coherence Tomography or Angiography of STEMI Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-04-01

Completion Date

2026-12-01

Last Updated

2024-04-01

Healthy Volunteers

Yes

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

Locations (1)

Northern Hospital

Shenyang, Liaoning, China