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Left Ventricular RemodelingPhase 4NCT02524964

Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction

A Phase 4 study testing sodium tanshinone IIA sulfonate in people with Left Ventricular Remodeling and Acute Myocardial Infarction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Approximately 60 patients with ST-segment elevation myocardial infarction successfully treated with primary percutaneous coronary intervention will be enrolled and randomized to receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same volume/day of normal saline. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
sodium tanshinone IIA sulfonate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
Dec 2015to Jul 2017
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Aged 18 years or over and under 80 years;
  • 2. First-time myocardial infarction on admission;
  • 3. Presence of STEMI who has successfully coronary recanalization by PCI within 12 h after the symptom onset;
  • 4. Willingness to provide informed consent prior to enrollment;
  • 5. Patient is able to comply with all follow-up evaluation

Who cannot join

  • 1. Contraindications to performance of CMRI [pacemakers, implantable cardioverter/defibrillator devices, cardiac resynchronization therapy (CRT), claustrophobia, metal implants (joint prosthesis, et al), history of penetrative eye lesion];
  • 2. Previous myocardial infarction, arrhythmia (including atrial fibrillation or bundle brunch block), significant valvular disease, and hypertrophic cardiomyopathy;
  • 3. Severe heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤30%) or cardiogenic shock;
  • 4. Serious impairment of renal function (glomerular filtration rate ≤50 mL/min per 1.73 m2);
  • 5. Hypohepatia (elevated of alanine aminotransferase and aspartate aminotransferase serum levels);
  • 6. Severe coagulopathy prior to randomization;
Show all 13Show fewer
  • 7. Malignant tumors or other life-threatening diseases with limited life expectancy <1 year;
  • 8. Significant neuropsychopathic condition precluding written informed consent;
  • 9. Pregnant and lactating women;
  • 10. Known radiographic contrast or sodium tanshinone IIA sulfonate allergy;
  • 11. Be on therapy with immunosuppressants;
  • 12. Currently participated in any other investigational therapeutic or device trial;
  • 13. Clinical follow-up over the next half years not possible

Trial locations and contacts

1 site in 1 country.

shuai mao, M.D. contact

86-20-81887233 ext. 32808

maoshuaitcm@hotmail.com

China1 site, 1 recruiting

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

    Minzhou Zhang, Dr., 86-20-81887233 ext. 32801, minzhouzhang@yeah.net

    Liheng Guo, Dr., 86-8187236 ext. 32907, lihengguo1@yeah.net

    Recruiting

Other trials in China

About this study

Official title: Effects of Sodium Tanshinone IIA Sulfonate on Left Ventricular Remodeling in Patients With ST-segment Elevation Myocardial Infarction Following Percutaneous Coronary Intervention

Approximately 60 patients with ST-segment elevation myocardial infarction successfully treated with primary percutaneous coronary intervention will be enrolled and randomized to receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same volume/day of normal saline.

The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with cardiac magnetic resonance imaging (MRI) at baseline and 6 months.

Read the detailed description

The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month change in LVEDVi measured using cardiac MRI when compared to placebo.

Secondary endpoints will include cardiac MRI measures of variations in microvascular obstruction, defect size, ventricular wall motion score, wall thickening, global LV ejection fraction, ventricular volumes (LV end-systolic/ diastolic volume) and myocardial perfusion during the same interval.

Furthermore, the investigators will determine the variation (change from baseline) of biomarkers indicating myocardial fibrosis (PICP, PIIINP, ICTP and MMPs) and NT-ProBNP at 1 and 6 months after AMI.

Additional efficacy endpoints will include 6-minute walk test, New York Heart Association functional classification, Seattle Angina Questionnaire score and incidence of cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization) at the 6-month follow-up will also be analyzed to evaluate the efficacy of sodium tanshinone IIA sulfonate treatment.

Being tested
sodium tanshinone IIA sulfonate, control
Keywords
left ventricular remodeling, cardiac magnetic resonance imaging, acute myocardial infarction
Medical subject headings
Ventricular Remodeling

What participants receive

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

  • sodium tanshinone IIA sulfonateDrug

    Also called sodium tanshinone IIA sulfonate injection

    eligible participants were randomized to receive sodium tanshinone IIA sulfonate injection (drip 80 mg/day for 7 days immediately after PCI)

  • controlOther

    Also called sodium chloride solution

    equivalent volume of sodium chloride solution

Study groups in NCT02524964
Study groupRoleWhat they receive
sodium tanshinone IIA sulfonateExperimentalsodium tanshinone IIA sulfonate (80 mg q.d. for 7 days)
Receives: Drug: sodium tanshinone IIA sulfonate
controlSham comparatorsame volume/day of normal saline.
Receives: Other: control

What is being measured

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

  1. left ventricular end-diastolic volume index

    The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month change in left ventricular end-diastolic volume index (mL/m^2) measured using cardiac magnetic resonance imaging .

    Measured: 6 months

Secondary outcomes (7)

  1. cardiac magnetic resonance imaging measures of LV remolding

    cardiac magnetic resonance imaging measures of variations in left ventricular end-systolic/ diastolic volume (mL) during the same interval.

    Measured: 6 months

  2. cardiac magnetic resonance imaging measures of microvascular obstruction

    cardiac magnetic resonance imaging measures of the frequency of delayed or absent wash-in of contrast agent into the infarct zone.

    Measured: 6 months

  3. variation (change from baseline) of biomarkers indicating myocardial fibrosis

    type 1 collagen telopeptide (ng/mL), aminoterminal propeptide of type I procollagen (ng/mL), aminoterminal propeptide of type III procollagen (ng/mL), matrix metalloproteinase2 (ng/mL), matrix metalloproteinase9 (ng/mL) at 1 and 6 months after AMI.

    Measured: 6 months

  4. major adverse cardiac event

    frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)

    Measured: 1 and 6 months

  5. 6-minute walk test

    A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)

    Measured: 6 months

  6. New York Heart Association functional classification

    I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc.

    II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

    III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.

    IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

    Measured: 6 months

  7. Seattle Angina Questionnaire score

    The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception). (in Units on a Scale).

    Measured: 6 months

Timeline

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

  1. First posted17 Aug 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJul 2017 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02524964
Sponsor's protocol ID
B2014-011-01
Status last verified
Aug 2016
First submitted
10 Aug 2015
Last updated
1 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • He X, Yang F, Wu Y, Lu J, Gao X, Zhu X, Yang J, Liu S, Xiao G, Pan X. Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect. J Virol. 2023 Oct 31;97(10):e0079623. doi: 10.1128/jvi.00796-23. Epub 2023 Sep 21.

    PubMed 37732786

  • Mao S, Li X, Wang L, Yang PC, Zhang M. Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study. Cardiovasc Drugs Ther. 2015 Dec;29(6):535-542. doi: 10.1007/s10557-015-6625-2.

    PubMed 26482376

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sodium tanshinone IIA sulfonate in people with Left Ventricular Remodeling and Acute Myocardial Infarction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 5 inclusion and 13 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 1 Sep 2016. 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 shuai mao, M.D. (86-20-81887233 ext. 32808, maoshuaitcm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

left ventricular end-diastolic volume index (time frame: 6 months). 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 NCT02524964, which also lists 2 linked publications.

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 1 Sep 2016.

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