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

Green Valley Group of China

Status and phase: Unknown; Phase 4

Conditions: STEMI - ST Elevation Myocardial Infarction

Treatments: Drug: Salvianolate injection; Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03045562

GV-MD-CT201602

Details and patient eligibility

About

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

Full 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.

Enrollment: 536 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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536 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Patients will be assigned to receive 100ml of normal saline

Treatment:

Drug: Normal saline

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Salvianolate injection