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

NCT ID: NCT03045562

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-20

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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STEMI - ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Patients will be assigned to receive 100ml of normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.

Experimental group

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

Group Type EXPERIMENTAL

Salvianolate injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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0.9% sodium chloride solution Salvianolate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Valley Group of China

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junbo Ge, doctor

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

Locations

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Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongying Liu, doctor

Role: CONTACT

Facility Contacts

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Hongying Liu, doctor

Role: primary

+86 21 64041990

Other Identifiers

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GV-MD-CT201602

Identifier Type: -

Identifier Source: org_study_id

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