Efficacy and Safety of an Early Phase Single-bolus r-SAK for Acute Myocardial Infarction

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early reperfusion may reduce the infarct size and improve the prognosis of patients. However, for patients whose first medical contact to emergency percutaneous coronary intervention (PCI) takes less than 2 hours, there is still lack of research evidence on whether thrombolytic therapy before PCI can increase the benefits of patients.

In this prospective, multicenter, randomized, controlled, excellence clinical trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trail group (r-SAK) or the control group (normal saline). The risk of major adverse cardiovascular events within 1 year and bleeding events within 30 days were observed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

1. Age 18~75 years old, weight ≥ 45kg, gender is not limited.

2. Diagnosis of acute ST-segment elevation myocardial infarction (both of the following):

(A) Ischemic chest pain lasting more than 30 minutes; (B) ECG indicates ST-segment elevation ≥ 0.1mV in 2 or more limb leads, or ST-segment elevation ≥ 0.2mV in 2 or more adjacent chest leads.

3. Time from onset of persistent ischemic chest pain to randomization ≤ 12 hours.

4. Coronary angiography and/or PCI are expected to be performed within 2 hours of r-SAK thrombolysis.

Exclusion Criteria:

1. Non-ST-segment elevation myocardial infarction.

2. STEMI with cardiogenic shock.

3. active bleeding or bleeding tendency, including Ⅲ, Ⅳ period history of retinopathy, retinal hemorrhage, gastrointestinal tract and urinary tract hemorrhage (1 month), ischemic stroke happened over the past 6 months, transient ischemic attack (TIA) happened over the past 6 weeks, hemorrhagic stroke in the past, unexplained platelet count < 100 x 10^9 / L or Hemoglobin < 100 g/L.

4. Having a history of central nervous system trauma or known intracranial aneurysm.

5. Recent (within 1 month) severe trauma, surgery or head injury.

6. Suspected aortic dissection, infective endocarditis.

7. Recent history of puncture which difficult hemostasis by compression (visceral biopsy, compartment puncture).

8. Long-term use and/or current use of anticoagulant drugs.

9. Hypertension not well controlled, Bp ≥ 180/110mmHg.

10. Having severe hepatic and renal impairment, including ALT, AST > 3 x ULN and eGFR<15 mL/min/1.73m^2 (calculated based on CKD-EPI equation).

11. Known allergies to r-SAK.

12. Pregnant, breastfeeding or planned pregnancy women and male patients with family planning.

13. Patients who have participated in other clinical trials in the past 3 months.

14. Having a history of myocardial infarction or CABG.

15. Having taken antiplatelet drugs after pain onset, such as clopidogrel, prasugrel, cilostazol etc.

16. Other reasons that patients considered unsuitable for inclusion by researchers.