OCT or Angiography Guided De-escalation of DAPT

Launched by SHENYANG NORTHERN HOSPITAL · Mar 24, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to manage patients who have experienced a heart attack (known as ST-Elevation Myocardial Infarction or STEMI) and are undergoing a procedure to open blocked arteries (called Percutaneous Coronary Intervention or PCI). The study is looking at how using advanced imaging technology called Optical Coherence Tomography (OCT) can help doctors place stents more effectively. After the procedure, the trial will also investigate whether switching from a stronger antiplatelet medication to a milder one can reduce the risk of bleeding without increasing the chances of heart problems.

To participate in this trial, you need to be between 18 and 85 years old, have been diagnosed with STEMI, and be willing to provide consent. However, there are certain conditions that may prevent someone from participating, such as recent major bleeding or certain heart conditions. If you qualify, you can expect to undergo the PCI procedure guided by OCT and then follow a specific antiplatelet regimen. This trial is an important step in finding safer treatment options for heart attack patients, aiming to improve their recovery while minimizing risks.

Gender

ALL

Eligibility criteria

• 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.