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

Primary Purpose

Unstable Angina

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
0.9% Sodium Chloride Injection
salvianolate injection
Sponsored by
Green Valley Group of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Angina

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese PLA General HospitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.

patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.

Outcomes

Primary Outcome Measures

symptom of angina pectoris

Secondary Outcome Measures

Seattle angina scale score
EQ-5D health scale
thrombolysis in myocardial infarction risk score
Incidence of cardiovascular and cerebrovascular events

Full Information

First Posted
January 20, 2017
Last Updated
January 27, 2017
Sponsor
Green Valley Group of China
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1. Study Identification

Unique Protocol Identification Number
NCT03037047
Brief Title
Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris
Official Title
Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Valley Group of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride Injection
Other Intervention Name(s)
Normal saline
Intervention Description
Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
Intervention Type
Drug
Intervention Name(s)
salvianolate injection
Other Intervention Name(s)
Salvianolate
Intervention Description
Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
Primary Outcome Measure Information:
Title
symptom of angina pectoris
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Seattle angina scale score
Time Frame
up to 28 days
Title
EQ-5D health scale
Time Frame
up to 28 days
Title
thrombolysis in myocardial infarction risk score
Time Frame
up to 28 days
Title
Incidence of cardiovascular and cerebrovascular events
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria Patient in line with 1979 WHO diagnostic criteria for UA Ages eligible for study: 60-85years (adult,senior) Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly Participates give written informed consent exclusion criteria NSTE-ACS caused by non atherosclerotic disease 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) Angina pectoris caused byanemia, methemoglobinemia and hypoxemia Abnormal thyroid function Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) Severe cardiopulmonary dysfunction Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate < 55),complete left bundle branch block 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 Recent 4 weeks underwent surgery and bleeding tendency Poor compliance At the same time in other clinical researches Allergic constitution
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongying Liu, doctor
Email
xiaowanzi010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li, doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospita
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongying Liu, doctor
Phone
+86 10 68182255
Email
xiaowanzi010@163.com
First Name & Middle Initial & Last Name & Degree
Xiaoying Li, doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31782009
Citation
Cui H, Li XY, Gao XW, Lu X, Wu XP, Wang XF, Zheng XQ, Huang K, Liu F, Luo Z, Yuan HS, Sun G, Kong J, Du XH, Zheng J, Liu HY, Zhang WJ. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population. Chin J Integr Med. 2019 Oct;25(10):728-735. doi: 10.1007/s11655-019-2710-x. Epub 2019 Nov 28.
Results Reference
derived

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

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