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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02158559
First received: May 29, 2014
Last updated: June 5, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Myocardial Infarction
Drug: Danhong Injection
Drug: Normal Saline
Phase 4

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

Further study details as provided by Beijing Bozhiyin T&S Co., Ltd.:

Primary Outcome Measures:
  • After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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;

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov Identifier: NCT02158559     History of Changes
Other Study ID Numbers: DH-140318-01
Study First Received: May 29, 2014
Last Updated: June 5, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014