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

June 5, 2014 updated by: Beijing Bozhiyin T&S Co., Ltd.

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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;
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;
Placebo Comparator: 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;
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Bozhiyin T&S Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DH-140318-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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