Compare Early With Deferred Invasive Strategy for STEMI Presenting 24-48 Hours From Symptom Onset

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Sep 29, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at two different approaches to treat patients who have suffered a heart attack, specifically a type called ST-segment elevation myocardial infarction (STEMI), and who show symptoms between 24 and 48 hours after the event. The goal is to find out whether treating these patients right away (early invasive strategy) is more effective than waiting a bit longer (deferred invasive strategy).

To be eligible for the trial, participants must be between 18 and 75 years old and have specific heart test results showing a type of heart attack. They should have experienced symptoms between 24 and 48 hours prior to joining the study and must provide consent to participate. If you join the trial, you can expect to receive careful monitoring and treatment based on the approach being studied. It's important to note that certain health conditions and previous treatments might prevent someone from participating, so potential volunteers should discuss their individual health situation with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 or over and less than 75 years old;
• • 2. ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads;
• • 3. Patents with STEMI with symptom onset between 24 and 48 hours before randomization;
• • 4. Signed informed consent form prior to trial participation.
• Exclusion Criteria:
• • 1. Patents with STEMI with symptom onset \<24h or \>48h or uncertain time onset;
• • 2. Prior administration of thrombolytic therapy or attempted PCI before randomization;
• • 3. Presence of indications for primary PCI, such as persistent chest pain, cardiogenic shock, life-threatening arrhythmias or cardiac arrest, severe acute heart failure, and mechanical complications;
• • 4. Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy;
• • 5. Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin);
• • 6. Congenital heart disease or severe valvular disease;
• • 7. eGFR \<30 ml/min/1.73 m2;
• • 8. History of malignant tumors;
• • 9. Combined with other diseases and life expectancy ≤12 months;
• • 10. Pregnancy;
• • 11. Inclusion in another clinical trial;
• • 12. Inability to provide informed consent or not available for follow-up judged by investigator.