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Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury (RESTORE)

Primary Purpose

Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Shenfu Injection

5% Glucose Injection

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 and <75 years.
First-time acute anterior STEMI scheduled for primary PCI.
ST segment elevation in at least two contiguous precordial leads according to electrocardiogram (>30 min).
Symptoms onset ≤12 hours.
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.
Written informed consent.

Exclusion Criteria:

Cardiogenic shock, serious heart failure (Killip class III or above), malignant ventricular arrhythmia, or mechanical complications.
Post cardiopulmonary resuscitation (CPR) (including cardioversion).
Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI).
Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg).
Prior myocardial infarction, PCI or coronary artery bypass graft.
Known severe hepatic insufficiency (AST/ALT >3-fold the upper limit of normal value) or known renal insufficiency.
Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.
Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months.
History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<100×109/L).
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).
Scheduled for CABG within one month after randomization.
Pregnancy, lactation, or potentially fertile women.
Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect.
Patients with contraindication to CMR (metal foreign body in the body, claustrophobia, etc.).
Participation in other clinical trial in recent 3 months.
Patients who cannot complete this trial or comply with the protocol.

Sites / Locations

Beijing Anzhen Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shenfu Injection

5% Glucose Injection

Arm Description

Outcomes

Primary Outcome Measures

Infarct size (% of left ventricular mass)

Infarct size was assessed by performing CMR imaging at 5±2 days after PCI

Secondary Outcome Measures

Microvascular obstruction (% of left ventricular mass)

Intramyocardial hemorrhage (% of left ventricular mass)

Area under the curve (AUC) of creatine kinase isoenzyme (CK-MB)

AUC of cardiac troponin I

Peak value of CK-MB and cTnI

ST segment resolution (%) according to ECG

TIMI flow grade

Corrected TIMI frame count (CTFC)

TIMI myocardial perfusion grade (TMPG)

Myocardial salvage index

Area at risk (myocardial edema, % of left ventricular mass)

Left ventricular end-diastolic volume (LVEDV)

Left ventricular end-systolic volume (LVESV)

Left ventricular ejection fraction (LVEF)

Major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization)

Individual events (including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization, re-hospitalization for heart failure)

Full Information

NCT ID

NCT04493840

First Posted

July 23, 2020

Last Updated

September 2, 2021

Sponsor

Beijing Anzhen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04493840

Brief Title

Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

Acronym

RESTORE

Official Title

Effect of Shenfu Injection on Myocardial Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 30, 2020 (Actual)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Shenfu Injection

Arm Type

Experimental

Arm Title

5% Glucose Injection

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Shenfu Injection

Intervention Description

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

Intervention Name(s)

5% Glucose Injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Infarct size (% of left ventricular mass)

Description

Infarct size was assessed by performing CMR imaging at 5±2 days after PCI

Time Frame

5±2 days after PCI

Secondary Outcome Measure Information:

Title

Microvascular obstruction (% of left ventricular mass)

Time Frame

5±2 days after PCI

Title

Intramyocardial hemorrhage (% of left ventricular mass)

Time Frame

5±2 days after PCI

Title

Area under the curve (AUC) of creatine kinase isoenzyme (CK-MB)

Time Frame

Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI

Title

AUC of cardiac troponin I

Time Frame

Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI

Title

Peak value of CK-MB and cTnI

Time Frame

72 hours after PCI

Title

ST segment resolution (%) according to ECG

Time Frame

24 hours after PCI

Title

TIMI flow grade

Time Frame

Immediately after PCI

Title

Corrected TIMI frame count (CTFC)

Time Frame

Immediately after PCI

Title

TIMI myocardial perfusion grade (TMPG)

Time Frame

Immediately after PCI

Title

Myocardial salvage index

Time Frame

5±2 days after PCI

Title

Area at risk (myocardial edema, % of left ventricular mass)

Time Frame

5±2 days after PCI

Title

Left ventricular end-diastolic volume (LVEDV)

Time Frame

5±2 days after PCI

Title

Left ventricular end-systolic volume (LVESV)

Time Frame

5±2 days after PCI

Title

Left ventricular ejection fraction (LVEF)

Time Frame

5±2 days after PCI

Title

Major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization)

Time Frame

30 days after PCI

Title

Individual events (including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization, re-hospitalization for heart failure)

Time Frame

30 days after PCI

Other Pre-specified Outcome Measures:

Title

Slow flow and no flow

Time Frame

Index procedure

Title

Malignant arrhythmia (ventricular fibrillation, ventricular tachycardia, etc.)

Time Frame

Index procedure

Title

Value of high-sensitivity C-reactive protein (Hs-CRP)

Time Frame

Immediately after admission (0 hour), and 24, 72 hours and 5 days after PCI

Title

Value of brain natriuretic peptide (BNP)

Time Frame

Immediately after admission (0 hour), and 24, 72 hours and 5 days after PCI

Title

The Myocardial Infarction Dimensional Assessment Scale (MIDAS)

Description

0 to 140 scores, higher scores mean worse outcome

Time Frame

6 hours and 30 days after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 and <75 years. First-time acute anterior STEMI scheduled for primary PCI. ST segment elevation in at least two contiguous precordial leads according to electrocardiogram (>30 min). Symptoms onset ≤12 hours. 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. Written informed consent. Exclusion Criteria: Cardiogenic shock, serious heart failure (Killip class III or above), malignant ventricular arrhythmia, or mechanical complications. Post cardiopulmonary resuscitation (CPR) (including cardioversion). Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI). Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg). Prior myocardial infarction, PCI or coronary artery bypass graft. Known severe hepatic insufficiency (AST/ALT >3-fold the upper limit of normal value) or known renal insufficiency. Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year. Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months. History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<100×109/L). 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). Scheduled for CABG within one month after randomization. Pregnancy, lactation, or potentially fertile women. Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect. Patients with contraindication to CMR (metal foreign body in the body, claustrophobia, etc.). Participation in other clinical trial in recent 3 months. Patients who cannot complete this trial or comply with the protocol.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shao-Ping Nie, MD, PhD

Phone

86-10-84005256

spnie@ccmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Wang, MD

Phone

86-10-84005255

spaceeye123@126.com

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shao-Ping Nie, MD, PhD

Phone

86-10-84005256

spnie@ccmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xiao Wang, MD

Phone

86-10-84005255

spaceeye123@126.com

First Name & Middle Initial & Last Name & Degree

Shao-Ping Nie, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

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