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

Unstable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03037047
• Other study ID #: GV-MD-CT201601
• Status: Recruiting
• Phase: Phase 4
• First received: January 20, 2017
• Last updated: January 27, 2017
• Start date: May 11, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2017
• Source: Green Valley Group of China
• Contact: Hongying Liu, doctor
• Email: xiaowanzi010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Unstable Angina

Intervention

Drug:
• 0.9% Sodium Chloride Injection
Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
• salvianolate injection
Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.

Locations

Country	Name	City	State
China	Chinese PLA General Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Green Valley Group of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom of angina pectoris		up to 14 days
Secondary	Seattle angina scale score		up to 28 days
Secondary	EQ-5D health scale		up to 28 days
Secondary	thrombolysis in myocardial infarction risk score		up to 28 days
Secondary	Incidence of cardiovascular and cerebrovascular events		up to 28 days