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SISTEMI: Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI

Sponsor
Green Valley Group of China (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03045562
Collaborator
(none)
536
Enrollment
1
Location
2
Arms
23.3
Anticipated Duration (Months)
23
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI

Condition or Disease Intervention/Treatment Phase
  • Drug: Normal saline
  • Drug: Salvianolate injection
 Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
536 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
Actual Study Start Date :
Jan 20, 2017
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control group

Patients will be assigned to receive 100ml of normal saline

Drug: Normal saline
Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
Other Names:
  • 0.9% sodium chloride solution

    		•
    Experimental: Experimental group

    Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline

    Drug: Salvianolate injection
    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.
    Other Names:
  • Salvianolate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TIMI flow grade [an average of 2 hours]

      Use TIMI flow grade to evaluate myocardial circulation perfusion

    2. TIMI myocardial perfusion grade [an average of 2 hours]

      Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion

    Secondary Outcome Measures

    1. ST-segment resolution [up to 90 minutes]

      Use ST-segment resolution to evaluate the epicardial blood flow perfusion

    2. myocardial contrast echocardiograph [up to 7 days]

      Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion

    3. creatine kinase isoenzyme [up to 48 hours]

      Use creatine kinase isoenzyme to evaluate myocardial infarct size

    4. major adverse cardiovascular events [an average of 30 days]

      all-caused death, re-infarction, target vessel revascularization, stroke

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Informed consent must be obtained prior to any study procedure.

    2. Age>18 years.

    3. Subjects of STEMI who underwent primary PCI within the first 12 hours.

    Exclusion Criteria:

    1. Allergic to Salvianolate injection

    2. Mechanical complications

    3. History of severe renal or hepatic insufficiency

    4. Pregnant or breastfeeding women

    5. Pool compliance,greater risks result from the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Hospital Affiliated to Fudan University Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Green Valley Group of China

    Investigators

    • Study Chair: Junbo Ge, doctor, Shanghai Zhongshan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Green Valley Group of China
    ClinicalTrials.gov Identifier:
    NCT03045562
    Other Study ID Numbers:
    • GV-MD-CT201602
    First Posted:
    Feb 7, 2017
    Last Update Posted:
    Feb 7, 2017
    Last Verified:
    Feb 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Feb 7, 2017