ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02709798
• Date of registration: 11/03/2016
• Prospective Registration: Yes
• Primary sponsor: Beijing Anzhen Hospital
• Public title: ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction SF-STEMI
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Shenfu Injection on Reperfusion Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Pilot Trial
• Date of first enrolment: April 2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02709798
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

China

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =18 and <75 years;

2. First-time acute anterior STEMI;

3. The time from onset of ischemic symptom to the time of initial PCI balloon inflation
=6 hours;

4. >0.1 mV ST segment elevation in at least two contiguous precordial leads according to
electrocardiogram;

5. Scheduled for primary PCI;

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

7. Written informed consent.

Exclusion Criteria:

1. Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis,
or myocarditis;

2. Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class
III and above) or mechanical complications;

3. Patients after cardiopulmonary resuscitation (CPR) (including cardioversion);

4. Patients who have already received thrombolytic therapy;

5. Prior myocardial infarction or coronary artery bypass surgery;

6. Known serious hepatic, renal, blood, respiratory, or neuropsychiatric diseases;

7. Malignant tumor, lymphoma, HIV-positive, or hepatitis;

8. Uncontrolled hypertension (systolic BP >160 mm Hg or a diastolic BP >100 mmHg on at
least two consecutive readings);

9. Patients with active bleeding, major surgery or trauma within 3 months and
cerebrovascular accident within 6 months;

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

11. Multi-vessel disease with non-culprit vessel intervention;

12. Breastfeeding, pregnant, 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 potential contraindication to CMR;

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

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Intervention(s)

Drug: 5% Glucose Injection

Drug: Shenfu Injection

Primary Outcome(s)

Infarct size [Time Frame: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI]

Secondary Outcome(s)

AUC of cardiac troponin I (cTnI) [Time Frame: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI]

Main adverse cardiovascular and cerebrovascular events (MACCE, including death, non-fatal myocardial infarction, target vessel revascularization, stroke, new-onset severe heart failure, re-hospitalization for heart failure) [Time Frame: up to 28 days after PCI]

Peak value of CK-MB and cTnI [Time Frame: 72 hours after PCI]

Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF) [Time Frame: up to 28 days after PCI]

ST segment resolution (%) according to ECG [Time Frame: up to 24 hours after PCI]

Secondary ID(s)

D99-2015(043)-TCM-4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.