Trial | NCT03037047  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    320
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 Started
May 11
2016
Primary Completion
Dec 31
2017
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Jan 31
2017
Estimate

Drug 0.9% Sodium Chloride Injection

Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.

  • Other names: Normal saline

Drug salvianolate injection

Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.

  • Other names: Salvianolate

Control group Placebo Comparator

patients will be treated by 0.9% sodium chloride injection on the basis of conventional therapy for 14 days.

Experimental group Experimental

patients will be treated by salvianolate injection on the basis of conventional therapy for 14 days.

Criteria 

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
No Results Posted