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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
Chinese PLA General Hospita
Beijing, Beijing Municipality, China
RECRUITINGsymptom of angina pectoris
Time frame: up to 14 days
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
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