Angina Clinical Trial
Official title:
Clinical Study of Combination Therapy for Angina of Coronary Heart Disease With Aspirin and Salvianolate Injection Based on Population Pharmacokinetics and Therapeutic Effect:A Randomized, Controlled Trial
To evaluate the therapeutic evaluation of combination therapy with aspirin and salvianolate injection based on the population pharmacokinetics and TEG.A prospective, multicenter, randomized, controlled clinical trial is used.A total of 120 patients will be recruited and will be divided into three groups,respectively salvianolate injection group,aspirin group and salvianolate injection and aspirin group，and the course of treatment is 10 days.
1. Effectiveness evaluation:Primary Outcome Measure:Change of TEG（R time, K time, α angle,
MA,CI,TPI）.Secondary Outcome Measures: Change of symptom score of the Seattle Angina
Questionnaiire(SAQ).Change of ECG abnormalities.Change of score of traditional Chinese
medicine(TCM) symptom curative effect rating scale. Change of platelet aggregation
measured by light transmittance aggregometry(LTA).Change of serum
lipids（TC、TG、HDL-C、LDL-C）.Change of fasting blood glucose.Population pharmacokinetics
test(the detection of the blood concentration of magnesium lithospermate B and
salicylic acid).
2. Safety evaluation:Change of PT,APTT,TT,FIB.Adverse events.Change of basic life
sign.Gastrointestinal symptoms.Change of stool routine.Change of routine blood
test.Change of urine routine.Change of liver function.Change of renal function.Change
of fecal occult blood.
3. Number of participants:120 participants will be divided into three groups, the
salvianolate group (n=40), the aspirin group(n=40) and the combination therapy group of
salvianolate injection and aspirin(n=40).
4. Interventions:salvianolate injection group: salvianolate injection, intravenously
infusion,0.2g/time, once a day; other routine treatment according to the condition of
the disease.Aspirin group: aspirin, oral administration method,0.1g/time, once a day;
other routine treatment according to the condition of the disease.Salvianolate
injection and aspirin group: salvianolate injection, intravenously infusion,0.2g/time,
once a day; aspirin, oral administration method,0.1g/time, once a day; other routine
treatment according to the condition of the disease.
5. Course of treatment：10 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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