Pirfenidone Treat Myocardial Fibrosis After Acute Myocardial Infarction

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute myocardial infarction (AMI) is myocardial necrosis caused by acute and continuous ischemia and hypoxia of coronary artery. It can be complicated with arrhythmia, shock or heart failure, which is often life-threatening. The disease is the most common in Europe and the United States, where about 1.5 million people suffer from myocardial infarction every year. China has shown an obvious upward trend in recent years, with at least 500000 new cases every year and at least 2 million current cases . At present, China has a high incidence rate of heart failure after myocardial infarction. The incidence of heart failure within 7 days after myocardial infarction is 19.3%, and the incidence of heart failure from 30 days to 6.7 years after myocardial infarction is 13.1%~37.5%. The incidence of heart failure after myocardial infarction significantly increases the risk of short-term and long-term death, and the prognosis is poor. At present, there is a lack of unified guidance and norms for the diagnosis, treatment and prevention and control strategies of heart failure after myocardial infarction. Cardiac remodeling is the basic pathological process of heart failure after myocardial infarction, and it is also one of the main factors affecting the prognosis of patients. Studies have shown that 30% of AMI have ventricular remodeling 6 months after percutaneous coronary intervention (PCI), and the risk of ventricular remodeling in anterior wall myocardial infarction is the highest. According to foreign literature data, the probability of ventricular remodeling after anterior wall acute myocardial infarction is about 13%, which is 1.9 times higher than that in other parts.Opening the infarct related coronary artery early can save the dying myocardium, reduce the infarct myocardial area and reduce the loss of cardiomyocytes.

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

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborator: Beijing Continent Pharmaceutical Co, Ltd.
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

1. Age 18 ~ 80 years old (including 18 and 80 years old), regardless of gender.

2. Patients with acute anterior myocardial infarction 2-4 weeks after PCI.

3. NT proBNP ≥ 800 pg / ml in patients with sinus rhythm and 2400 pg / ml in patients with atrial fibrillation.

4. LVEF <50%.

5. The patients volunteered to participate in the trial, with good compliance and the ability to understand and sign the informed consent before the study

Exclusion Criteria:

1. Those who do not meet any of the inclusion criteria.

2. Patients with non acute anterior myocardial infarction.

3. Patients without PCI after myocardial infarction.

4. Glomerular filtration rate (CKD-EPI equation) < 30 ml / min / 1.73 m2.

5. Moderate or severe liver cirrhosis, or TBIL > 2 times ULN, ALT or AST > 3 times ULN caused by non cardiac reasons.

6. Patients with malignant tumors.

7. Patients with dysphagia or clinical signs of absorption disorder or requiring parenteral nutrition.

8. Patients with active peptic ulcer.

9. Severe pulmonary hypertension (pulmonary systolic pressure > 70mmhg).

10. Other diseases or complications that may affect the participation in the trial or put the patient at risk based on the judgment of the investigator.

11. Allergic to the test drug or its components (e.g., lactose).

12. Major surgery is planned during treatment.

13. Women who are pregnant, breastfeeding or planning to become pregnant during the trial.

14. Women of childbearing age are unwilling or unable to use highly effective contraceptive methods 28 days before administration or 3 months after administration.

15. According to the researchers, the patients had alcohol or drug abuse.

16. Patients with mental illness.

17. Participate in clinical trials of other drugs.

18. The researchers judged the participants who were unwell.

19. Patients who need to use Nintedanib, pirfenidone and Amifostine at the same time.