Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate whether perioperative use of Shenfu Injection, as compared to placebo, could reduce infarct size assessed by cardiac magnetic resonance (CMR) in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

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

Details

• Lead Sponsor: Beijing Anzhen Hospital

Criteria

Inclusion Criteria:

1. Age ≥18 and <75 years.

2. First-time acute anterior STEMI scheduled for primary PCI.

3. ST segment elevation in at least two contiguous precordial leads according to electrocardiogram (>30 min).

4. Symptoms onset ≤12 hours.

5. The presence of proximal or middle left anterior descending branch (LAD) occlusion with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram.

6. Written informed consent.

Exclusion Criteria:

1. Cardiogenic shock, serious heart failure (Killip class III or above), malignant ventricular arrhythmia, or mechanical complications.

2. Post cardiopulmonary resuscitation (CPR) (including cardioversion).

3. Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI).

4. Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg).

5. Prior myocardial infarction, PCI or coronary artery bypass graft.

6. Known severe hepatic insufficiency (AST/ALT >3-fold the upper limit of normal value) or known renal insufficiency.

7. Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.

8. Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months.

9. History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<100×109/L).

10. Patients who require simultaneous intervention of left main disease during primary PCI or those with multi-vessel disease who plan to intervene in non-culprit vessels within 7 days (simultaneous or staged).

11. Scheduled for CABG within one month after randomization.

12. Pregnancy, lactation, or potentially fertile women.

13. Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect.

14. Patients with contraindication to CMR (metal foreign body in the body, claustrophobia, etc.).

15. Participation in other clinical trial in recent 3 months.

16. Patients who cannot complete this trial or comply with the protocol.