Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

Last updated: September 2, 2021
Sponsor: Beijing Anzhen Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Hypercholesterolemia

Blood Clots

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT04493840
2019013
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 toelectrocardiogram (>30 min).
  4. Symptoms onset ≤12 hours.
  5. The presence of proximal or middle left anterior descending branch (LAD) occlusionwith pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram.
  6. Written informed consent.

Exclusion

Exclusion Criteria:

  1. Cardiogenic shock, serious heart failure (Killip class III or above), malignantventricular 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 PCIor 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 orpatients 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.

Study Design

Total Participants: 326
Study Start date:
July 30, 2020
Estimated Completion Date:
August 31, 2022

Study Description

Shenfu injection is a traditional Chinese medicine formulation containing ginseng (Panax; family: Araliaceae) and aconite (Radix aconiti lateralis preparata, Aconitum carmichaeli Debx; family: Ranunculaceae) with Ginsenosides and aconite alkaloids as the main active ingredients. Its quality is strictly controlled in compliance with the standard of the China Ministry of Public Health (official approval code: certification number Z20043117; No. 110804, Ya'an, China). Animal studies have shown that Shenfu injection has protective effects against reperfusion injury through multiple pharmacologic effects, including scavenging free radicals, inhibiting inflammatory mediators, suppressing cell apoptosis, and inhibiting calcium overload. However, few data are available regarding its efficacy in humans. We aimed to determine whether perioperative use of Shenfu injection, as compared to placebo, might reduce infarct size in patients with STEMI undergoing primary PCI.

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

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