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

Myocardial Infarction Clinical Trial

— Danhong  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02158559
• Other study ID #: DH-140318-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 29, 2014
• Last updated: June 5, 2014
• Start date: March 2014

Study information

• Verified date: June 2014
• Source: Beijing Bozhiyin T&S Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• 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;
• 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;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Bozhiyin T&S Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.		1 week	No