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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03037047
Study type Interventional
Source Green Valley Group of China
Contact Hongying Liu, doctor
Email xiaowanzi010@163.com
Status Recruiting
Phase Phase 4
Start date May 11, 2016
Completion date December 31, 2018
View Details
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