STEMI - ST Elevation Myocardial InfarctionPhase 4SISTEMINCT03045562
Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI
A Phase 4 study testing Normal saline and Salvianolate injection in people with STEMI - ST Elevation Myocardial Infarction, run by Green Valley Group of China at 1 site in China.
Trial summary
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Normal saline and Salvianolate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2017to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent must be obtained prior to any study procedure.
- Age>18 years.
- Subjects of STEMI who underwent primary PCI within the first 12 hours.
Who cannot join
- Allergic to Salvianolate injection
- Mechanical complications
- History of severe renal or hepatic insufficiency
- Pregnant or breastfeeding women
- Pool compliance,greater risks result from the study
Trial locations and contacts
1 site in 1 country.
Hongying Liu, doctor contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Hongying Liu, doctor, +86 21 64041990, yuyangxian021@163.com
Junbo Ge, doctor
About this study
Official title: Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI
Read the detailed description
This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic，CK-MB.The major adverse cardiovascular events will be observed.
- Being tested
- Normal saline, Salvianolate injection
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called 0.9% sodium chloride solution
Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
Salvianolate injectionDrug
Also called Salvianolate
Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients will be assigned to receive 100ml of normal saline Receives: Drug: Normal saline |
| Experimental group | Experimental | Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline Receives: Drug: Salvianolate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIMI flow grade
Use TIMI flow grade to evaluate myocardial circulation perfusion
Measured: an average of 2 hours
TIMI myocardial perfusion grade
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion
Measured: an average of 2 hours
Secondary outcomes (4)
ST-segment resolution
Use ST-segment resolution to evaluate the epicardial blood flow perfusion
Measured: up to 90 minutes
myocardial contrast echocardiograph
Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion
Measured: up to 7 days
creatine kinase isoenzyme
Use creatine kinase isoenzyme to evaluate myocardial infarct size
Measured: up to 48 hours
major adverse cardiovascular events
all-caused death, re-infarction, target vessel revascularization, stroke
Measured: an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start20 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Valley Group of China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, doctor, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045562
- Sponsor's protocol ID
- GV-MD-CT201602
- Acronym
- SISTEMI
- Status last verified
- Feb 2017
- First submitted
- 20 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
- ClinicalTrials.gov ID
- NCT03045562
- Acronym / sponsor ID
- SISTEMI / GV-MD-CT201602
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Green Valley Group of ChinaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI
Detailed description
This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic，CK-MB.The major adverse cardiovascular events will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Normal salinePatients will be assigned to receive 100ml of normal saline |
| Experimental group | Experimental | Drug: Salvianolate injectionPatients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent must be obtained prior to any study procedure.
- Age>18 years.
- Subjects of STEMI who underwent primary PCI within the first 12 hours.
Key exclusion criteria (5 listed)
- Allergic to Salvianolate injection
- Mechanical complications
- History of severe renal or hepatic insufficiency
- Pregnant or breastfeeding women
- Pool compliance,greater risks result from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineAlso: 0.9% sodium chloride solutionPatients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days. | Drug | Control group |
| Salvianolate injectionAlso: SalvianolatePatients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days. | Drug | Experimental group |
Primary outcome
TIMI flow grade
Time frame: an average of 2 hours
Use TIMI flow grade to evaluate myocardial circulation perfusion
TIMI myocardial perfusion grade
Time frame: an average of 2 hours
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion
4 secondary outcomes
ST-segment resolution
Time frame: up to 90 minutes
myocardial contrast echocardiograph
Time frame: up to 7 days
creatine kinase isoenzyme
Time frame: up to 48 hours
major adverse cardiovascular events
Time frame: an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongying Liu, doctor contact
Junbo Ge, doctor study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal saline and Salvianolate injection in people with STEMI - ST Elevation Myocardial Infarction, run by Green Valley Group of China 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 3 inclusion and 5 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 7 Feb 2017. 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 Hongying Liu, doctor (yuyangxian021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIMI flow grade (time frame: an average of 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2017.