Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction

• Status: Completed
• Trial end date: 2021-11-18
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter randomized double-blind placebo parallel control design was used in this study.60 subjects eligible for inclusion will be randomly assigned to either a low-dose (0.25ug/kg) medium-dose (0.5ug/kg) high-dose (2.0ug/kg) experimental drug group or a control group (placebo) at a ratio of 1:1:1:1.After randomization, subjects received the experimental drug or placebo once a day, intravenously, on day 2 to 7, 12 hours and 4 hours after PCI.Ninety days after PCI were observed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Northland Biotech. Co., Ltd.

Criteria

Inclusion Criteria:

1. The subject or its legal representative will voluntarily participate in the study and sign the informed consent;

2. Age 18 and 75, regardless of gender;

3. STEMI patients with left anterior descending branch single-artery middle occlusion (TIMI grading 0~1, see Appendix 1 for TIMI grading) and receiving PCI;

4. No obvious collateral of coronary artery (Rentrop grade 0~1,Rentrop grade see Appendix 2);

5. Chest pain occurred for 6 hours and 12 hours before PCI;

6. TIMI grade 3 after PCI;

7. All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier contraceptive methods, abstinence) during the study period and up to 6 months after the last administration, and women of childbearing age must test negative for pregnancy before administration.

Exclusion Criteria:

1. Patients who have a history of myocardial infarction or have received coronary artery acute thrombolytic interventional therapy with bypass surgery;

2. patients who received thrombolytic therapy after onset;

3. patients who were clearly diagnosed as acute heart failure (Killip grade II,Killip classification in annex 3);

4. Severe arrhythmia that cannot be corrected;

5. Aortic dissection or suspected presence;

6. Severe liver and kidney dysfunction or severe depletion, etc;

7. major surgical history or hemorrhagic stroke in half a year;

8. Has or has a history of malignancy;

9. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg in patients with hypertension after active antihypertensive treatment;

10. Clinically, he had a significant history of allergy, especially to mannitol, drugs, protein preparations and biological products;

11. Screening of patients who participated in other clinical studies within the first 3 months;

12. Failure to perform CMR test: such as claustrophobia, renal failure (eGFR < 30ml/min);

13. Other conditions not considered suitable for inclusion by the researcher.