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

Phase 4

• Conditions: Unstable Angina
• Interventions: Drug: 0.9% Sodium Chloride Injection; Drug: salvianolate injection

• Registration Number: NCT03037047
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-27
• Last Update Submitted: 2017-01-27
• Study First Posted: 2017-01-31
• Last Update Posted: 2017-01-31
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	0.9% Sodium Chloride Injection	patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.
Experimental group	salvianolate injection	patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.

Primary Outcome Measures

Name	Time	Method
symptom of angina pectoris	up to 14 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospita; 🇨🇳 Beijing, Beijing, China