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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unstable Angina

Intervention / Treatment
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* Drug: 0.9% Sodium Chloride Injection
* Drug: salvianolate injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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<br>* Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.<br>* Other names: Normal saline;|
| Experimental: Experimental group<br>patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days. | Drug: salvianolate injection<br>* Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.<br>* Other names: Salvianolate;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |