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

Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Unstable Angina
• Intervention / Treatment: Drug: 0.9% Sodium Chloride Injection; Drug: salvianolate injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hongying Liu, doctor; Email: xiaowanzi010@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospita
      • Contact: Hongying Liu, doctor; Phone Number: +86 10 68182255; Email: xiaowanzi010@163.com
      • Principal Investigator: Xiaoying Li, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Salvianolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
symptom of angina pectoris	up to 14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Seattle angina scale score	up to 28 days
EQ-5D health scale	up to 28 days
thrombolysis in myocardial infarction risk score	up to 28 days
Incidence of cardiovascular and cerebrovascular events	up to 28 days

Collaborators and Investigators

• Sponsor: Green Valley Group of China
• Investigators: Study Chair: Xiaoying Li, doctor, Chinese PLA General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Unstable
• Other Study ID Numbers: GV-MD-CT201601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No