Overview

This trial is active, not recruiting.

Condition myocardial infarction
Treatments danhong injection, normal saline
Phase phase 4
Sponsor Beijing Bozhiyin T&S Co., Ltd.
Start date March 2014
End date December 2015
Trial size 180 participants
Trial identifier NCT02158559, DH-140318-01

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
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;
(Placebo Comparator)
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;
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;

Primary Outcomes

Measure
After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.
time frame: 1 week

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Beijing Bozhiyin T&S Co., Ltd..