the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.

NCT ID: NCT02158559

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

Brief Summary

This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Detailed Description

Research Topic.

• A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery.

Research Purpose.

• This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Research design.

• A randomized, double-blind, placebo-controlled, multi-center clinical trial.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Danhong Injection

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Group Type: EXPERIMENTAL

Danhong Injection

Intervention Type: DRUG

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Normal Saline

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Interventions

Danhong Injection

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Intervention Type: DRUG

Normal Saline

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery.
• 18≤Age≤75;
• Agreed to join in the study and signed the inform consent form.

Exclusion Criteria

• Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree.
• Past history of PCI and CABG
• Acute or chronic infectious diseases(for example severe pneumonia);
• Recent history of hemorrhagic stroke(within six months)
• Combined with liver and kidney dysfunction;
• History of valvular heart disease;
• Congenital heart disease or Pulmonary hypertension;
• All kinds of history of cardiomyopathy;
• Bleeding and other thrombotic diseases;
• Severe anemia , thrombocytopenia , Other diseases of the blood system;
• Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor;
• Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Bozhiyin T&S Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DH-140318-01

Identifier Type: -

Identifier Source: org_study_id