NCT02694848

Clinical Study of Combination Therapy for Angina of Coronary Heart Disease With Aspirin and Salvianolate Injection

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Angina

Interventions

Type	Name	Description
DRUG	Salvianolate injection	Traditional Chinese medicine injection，a kind of innovative drugs developed by Shanghai institute of materia medica, Chinese academy of sciences after 13 years of research and development.the content of magnesium acetate was 80%, and the other 20% were magnesium acetate.It has the function of promoting blood circulation,removing blood stasis and blood stasis,and is used for treating coronary heart disease with stable angina pectoris.
DRUG	Aspirin	Molecular chemical formula: C9H8O4,molecular structure type: CH3COOC6H4COOH. It has the role of anti thrombosis In vivo, and it can inhibit the release of the platelet reaction, inhibit platelet aggregation, which is related to the reduction of TXA2 generation. Clinically itused to prevent the onset of cardiovascular and cerebrovascular diseases.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2016-03-01
• Last updated: 2016-03-01

Locations

1 site across 1 country: China