Trials / Not Yet Recruiting
Not Yet RecruitingNCT06339021
OCT or Angiography Guided De-escalation of DAPT
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
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Shenyang Northern Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2024-04-01
- Last updated
- 2024-04-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06339021. Inclusion in this directory is not an endorsement.