Overview

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.