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

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Angina

Treatments: Drug: Salvianolate injection; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02694848

EBM

Details and patient eligibility

About

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.

Full description

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). 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. 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). 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. Course of treatment：10 days.

Enrollment: 120 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient age 35-75 years old
• Grade II diagnostic criteria for chronic stable angina pectoris
• Diagnostic criteria of blood stasis type
• Signed informed consent

Exclusion criteria

• Drug allergy to the test
• There is a family or personal history of hemorrhagic disease
• Platelet count < 100 * nine times square 10/L or > 450 *nine times square 10/L
• Hemoglobin < 90g/L
• ALT, AST higher than the upper limit of 2 times, BUN, Cr higher than the upper limit
• Drugs such as the use of clopidogrel, clopidogrel, Hua Falin or heparin in the last 2 weeks to take blood circulation drugs or other antiplatelet, anticoagulant or non steroidal anti-inflammatory drugs
• Heart failure three degrees, two degrees in patients with heart failure
• A history of trauma or surgery in the past 2 weeks
• Combined coronary heart disease myocardial infarction and cerebral blood vessels, liver, kidney, hematopoietic system severe primary disease, malignant tumor, mental disease patients, as well as hyperthyroidism, cervical spondylosis, stomach and esophageal reflux and other patients with chest pain
• Organ transplantation, AIDS, long-term use of immunosuppressive agents and other immune deficiency
• Pregnant or lactating women
• Other clinical trial participants who are taking part in the evaluation of the results of this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Salvianolate injection group

Other group

Description:

Salvianolate injection,intravenously infusion,0.2g/time,once a day;other routine treatment according to the condition of the disease

Treatment:

Drug: Salvianolate injection

Aspirin group

Active Comparator group

Description:

Aspirin,oral administration method,0.1g/time,once a day;other routine treatment according to the condition of the disease

Treatment:

Drug: Aspirin

Salvianolate injection and aspirin group

Experimental group

Description:

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

Treatment:

Drug: Aspirin

Drug: Salvianolate injection