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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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. 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.
Sponsor: Green Valley Group of China

Current Primary Outcome: symptom of angina pectoris [ Time Frame: up to 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Green Valley Group of China

Dates:
Date Received: January 20, 2017
Date Started: May 11, 2016
Date Completion: December 31, 2018
Last Updated: January 27, 2017
Last Verified: January 2017