OCT or Angiography Guided De-escalation of DAPT

Shenyang Northern Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Neointimal Coverage; Optical Coherence Tomography; ST Elevation Myocardial Infarction; Antiplatelet De-escalation; Dual Antiplatelet Therapy

Treatments: Drug: DAPT de-escalation; Drug: default DAPT regimen; Procedure: Conventional angiography-based PCI; Procedure: OCT-guided PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT06339021

DAPT-OCT

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 ~ 85 years old adult patients;
2. Patients diagnosed with STEMI and undergoing PCI.
3. Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion criteria

1. Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
2. Allergy to aspirin or clopidogrel or ticagrelor;
3. Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
4. Platelet count < 50 × 109/L;
5. Major bleeding during the past 12 months;
6. Any form of oral, long-term anticoagulation therapy;
7. Pregnancy or lactation;
8. Suspected aortic dissection;
9. Coronary CT-negative patients;
10. Life expectancy <1 year;
11. Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
12. Comorbid conditions included the presence of any of the following: cardiogenic shock, chronic congestive heart failure with NYHA classes III or IV, left ventricular ejection fraction (LVEF) < 35% at transthoracic echocardiography, hypotension with SBP < 90mmHg and/or DBP < 60mmHg, severe arrhythmia (including high-degree AV block, sick sinus syndrome, sustained ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, hepatic insufficiency due to non-cardiac causes (ALT or AST more than three times the upper limit of the institution's normal reference ranges), cirrhosis, severe renal failure (eGFR < 30ml/min/1.73m2);
13. Surgery plan within 30 days;
14. Psychiatric abnormalities or alcohol dependence;
15. Patients who are participating in other clinical trials;
16. Unable to tolerate 1 month of DAPT;
17. Angiographic triple vessel disease coronary disease;
18. Other situations judged by the investigators not to be suitable for the clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups

OCT-guided PCI and DAPT De-escalation

Experimental group

Description:

OCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients

Treatment:

Drug: DAPT de-escalation

Procedure: OCT-guided PCI

OCT-guided PCI and default DAPT regimen

Experimental group

Description:

OCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients

Treatment:

Procedure: OCT-guided PCI

Drug: default DAPT regimen

Conventional angiography-based PCI and DAPT De-escalation

Experimental group

Description:

Conventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients

Treatment:

Drug: DAPT de-escalation

Procedure: Conventional angiography-based PCI

Conventional angiography-based PCI and default DAPT regimen

Active Comparator group

Description:

Conventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients

Treatment:

Procedure: Conventional angiography-based PCI

Drug: default DAPT regimen