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Myocardial InfarctionPhase 4RESTORENCT04493840

Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

A Phase 4 study testing Shenfu Injection and 5% Glucose Injection in people with Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Shenfu Injection and 5% Glucose Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
326 participants
Where
1 siteChina
Study dates
30 Jul 2020to 31 Aug 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Shao-Ping Nie, MD, PhD contact

86-10-84005256

spnie@ccmu.edu.cn

Xiao Wang, MD contact

86-10-84005255

spaceeye123@126.com

China1 site, 1 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

    Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@ccmu.edu.cn

    Xiao Wang, MD, 86-10-84005255, spaceeye123@126.com

    Recruiting

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Shenfu Injection, 5% Glucose Injection
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shenfu InjectionDrug

    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 InjectionDrug

    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.

Study groups in NCT04493840
Study groupRoleWhat they receive
Shenfu InjectionExperimentalNot described
Receives: Drug: Shenfu Injection
5% Glucose InjectionPlacebo comparatorNot described
Receives: Drug: 5% Glucose Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infarct size (% of left ventricular mass)

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

    Measured: 5±2 days after PCI

Secondary outcomes (16)

  1. Microvascular obstruction (% of left ventricular mass)

    Measured: 5±2 days after PCI

  2. Intramyocardial hemorrhage (% of left ventricular mass)

    Measured: 5±2 days after PCI

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

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

  4. AUC of cardiac troponin I

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

  5. Peak value of CK-MB and cTnI

    Measured: 72 hours after PCI

  6. ST segment resolution (%) according to ECG

    Measured: 24 hours after PCI

  7. TIMI flow grade

    Measured: Immediately after PCI

  8. Corrected TIMI frame count (CTFC)

    Measured: Immediately after PCI

  9. TIMI myocardial perfusion grade (TMPG)

    Measured: Immediately after PCI

  10. Myocardial salvage index

    Measured: 5±2 days after PCI

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

    Measured: 5±2 days after PCI

  12. Left ventricular end-diastolic volume (LVEDV)

    Measured: 5±2 days after PCI

  13. Left ventricular end-systolic volume (LVESV)

    Measured: 5±2 days after PCI

  14. Left ventricular ejection fraction (LVEF)

    Measured: 5±2 days after PCI

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

    Measured: 30 days after PCI

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

    Measured: 30 days after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start30 Jul 2020
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
326 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493840
Sponsor's protocol ID
2019013
Acronym
RESTORE
Status last verified
Sep 2021
First submitted
23 Jul 2020
Last updated
10 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang X, Guo R, Guo Y, Guo Q, Yan Y, Gong W, Zheng W, Wang H, Xu L, Ai H, Que B, Yan X, Ma X, Nie S. Rationale and design of the RESTORE trial: A multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the effect of Shenfu injection on myocardial injury in STEMI patients after primary PCI. Am Heart J. 2023 Jun;260:9-17. doi: 10.1016/j.ahj.2023.02.005. Epub 2023 Feb 22.

    PubMed 36822255

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shenfu Injection and 5% Glucose Injection in people with Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shao-Ping Nie, MD, PhD (86-10-84005256, spnie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct size (% of left ventricular mass) (time frame: 5±2 days after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04493840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.

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