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
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Neointimal thickness after DES implantation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •Major bleeding during the past 12 months;
- •Any form of oral, long-term anticoagulation therapy;
- •Pregnancy or lactation;
- •Suspected aortic dissection;
- •Coronary CT-negative patients;
- •Life expectancy <1 year;
- •Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
- •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);
- •Surgery plan within 30 days;
- •Psychiatric abnormalities or alcohol dependence;
- •Patients who are participating in other clinical trials;
- •Unable to tolerate 1 month of DAPT;
- •Angiographic triple vessel disease coronary disease;
- •Other situations judged by the investigators not to be suitable for the clinical trial.
研究组 & 干预措施
Conventional angiography-based PCI and DAPT De-escalation
Conventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients
干预措施: Conventional angiography-based PCI (Procedure)
OCT-guided PCI and DAPT De-escalation
OCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients
干预措施: OCT-guided PCI (Procedure)
OCT-guided PCI and DAPT De-escalation
OCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients
干预措施: DAPT de-escalation (Drug)
OCT-guided PCI and default DAPT regimen
OCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients
干预措施: OCT-guided PCI (Procedure)
OCT-guided PCI and default DAPT regimen
OCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients
干预措施: default DAPT regimen (Drug)
Conventional angiography-based PCI and DAPT De-escalation
Conventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients
干预措施: DAPT de-escalation (Drug)
Conventional angiography-based PCI and default DAPT regimen
Conventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients
干预措施: Conventional angiography-based PCI (Procedure)
Conventional angiography-based PCI and default DAPT regimen
Conventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients
干预措施: default DAPT regimen (Drug)
结局指标
主要结局
Neointimal thickness after DES implantation
时间窗: At 12-month follow up after PCI
Stent and luminal cross-sectional areas (CSAs) were measured. Neointimal CSA was calculated as stent CSA minus lumen CSA. Neointimal thickness was measured as the distance between endoluminal surface of neointima and strut, which was obtained at 12-month follow-up.
次要结局
- BARC types 2-5 bleeding(During 12-month follow up)
- Major adverse cardiovascular and cerebrovascular events (MACCE)(During 12-month follow up)
- In-stent thrombosis(During 12-month follow up)
研究者
Han Yaling
MD
Shenyang Northern Hospital