Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037047
Recruitment Status : Unknown
Verified January 2017 by Green Valley Group of China.
Recruitment status was:  Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Green Valley Group of China

Brief Summary:
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.

Condition or disease Intervention/treatment Phase
Unstable Angina Drug: 0.9% Sodium Chloride Injection Drug: salvianolate injection Phase 4

Detailed Description:
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.
Actual Study Start Date : May 11, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Placebo Comparator: Control group
patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.
Drug: 0.9% Sodium Chloride Injection
Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
Other Name: Normal saline

Experimental: Experimental group
patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.
Drug: salvianolate injection
Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
Other Name: Salvianolate




Primary Outcome Measures :
  1. symptom of angina pectoris [ Time Frame: up to 14 days ]

Secondary Outcome Measures :
  1. Seattle angina scale score [ Time Frame: up to 28 days ]
  2. EQ-5D health scale [ Time Frame: up to 28 days ]
  3. thrombolysis in myocardial infarction risk score [ Time Frame: up to 28 days ]
  4. Incidence of cardiovascular and cerebrovascular events [ Time Frame: up to 28 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

inclusion criteria

  1. Patient in line with 1979 WHO diagnostic criteria for UA
  2. Ages eligible for study: 60-85years (adult,senior)
  3. Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly
  4. Participates give written informed consent

exclusion criteria

  1. NSTE-ACS caused by non atherosclerotic disease
  2. Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis)
  3. Angina pectoris caused byanemia, methemoglobinemia and hypoxemia
  4. Abnormal thyroid function
  5. Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg)
  6. Severe cardiopulmonary dysfunction
  7. Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate < 55),complete left bundle branch block
  8. Combined liver and kidney and hematopoietic system and other serious diseases, liver function (ALT, AST) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2
  9. Recent 4 weeks underwent surgery and bleeding tendency
  10. Poor compliance
  11. At the same time in other clinical researches
  12. Allergic constitution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037047


Contacts
Layout table for location contacts
Contact: Hongying Liu, doctor xiaowanzi010@163.com

Locations
Layout table for location information
China, Beijing
Chinese PLA General Hospita Recruiting
Beijing, Beijing, China, 100853
Contact: Hongying Liu, doctor    +86 10 68182255    xiaowanzi010@163.com   
Principal Investigator: Xiaoying Li, doctor         
Sponsors and Collaborators
Green Valley Group of China
Investigators
Layout table for investigator information
Study Chair: Xiaoying Li, doctor Chinese PLA General Hospital

Layout table for additonal information
Responsible Party: Green Valley Group of China
ClinicalTrials.gov Identifier: NCT03037047     History of Changes
Other Study ID Numbers: GV-MD-CT201601
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Angina Pectoris
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms