Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2022-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Shenfu Injection

Group Type EXPERIMENTAL

Shenfu Injection

Intervention Type DRUG

80ml Shenfu Injection + 70ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

5% Glucose Injection

Group Type PLACEBO_COMPARATOR

5% Glucose Injection

Intervention Type DRUG

150 ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

Interventions

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Shenfu Injection

80ml Shenfu Injection + 70ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

Intervention Type DRUG

5% Glucose Injection

150 ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No