OCT or Angiography Guided De-escalation of DAPT

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Northern Hospital

About this trial

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.

Eligibility criteria

Qualifiers

18 ~ 85 years old adult patients;

Patients diagnosed with STEMI and undergoing PCI.

Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Disqualifiers

Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months;

Allergy to aspirin or clopidogrel or ticagrelor;

Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;

Platelet count < 50 × 109/L;

Trial design

Treatments tested in this trial

  • OCT-guided PCI
  • Conventional angiography-based PCI
  • DAPT de-escalation
  • default DAPT regimen

Treatment groups

80 Participants
are divided into 4 treatment groups

Sponsors and collaborators