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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02694848
• Other study ID #: EBM
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 14, 2016
• Last updated: February 24, 2016
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2016
• Source: China Academy of Chinese Medical Sciences
• Contact: Lianxin Wang, doctor
• Phone: 86-13521781839
• Email: wanglianxin_tcm[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina
• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	General Hospital of Beijing PLA Military Region, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Guangdong Provincial Hospital of Traditional Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of PT	An index to reflect the status of the extrinsic coagulation system	Change from base line on the tenth day	Yes
Other	Adverse events		Change from base line on the tenth day	Yes
Other	Change of basic life sign	In the medical care system, body temperature, blood pressure and pulse are the most important and basic three physiological parameters of the vital signs	Change from base line on the tenth day	Yes
Other	Gastrointestinal symptoms		Change from base line on the tenth day	Yes
Other	Change of stool routine	The stool routine includes stool properties, lipid droplets, and white blood cell count	Change from base line on the tenth day	Yes
Other	Change of routine blood test	The routine blood test includes white blood cell count, neutral cell ratio, lymphocyte ratio, single nuclear cell ratio, red blood cell count, hemoglobin, platelet count	Change from base line on the tenth day	Yes
Other	Change of urine routine	The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar	Change from base line on the tenth day	Yes
Other	Change of liver function	The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase	Change from base line on the tenth day	Yes
Other	Change of renal function	The renal function includes creatinine,usea nitrogen	Change from base line on the tenth day	Yes
Other	Change of fecal occult blood	In order to monitor the safety of the digestive tract (if there is bleeding)	Change from base line on the tenth day	Yes
Other	Change of APTT	An index to reflect the status of endogenous coagulation system	Change from base line on the tenth day	Yes
Other	Change of TT	An index to reflect the time consuming from the fibrinogen into fibrin	Change from base line on the tenth day	Yes
Other	Change of FIB	An index to reflect the content of fibrinogen	Change from base line on the tenth day	Yes
Primary	Change of thromboela-stogram(R time,K time,a angle,MA?CI?TPI)	Thromboela-stogram(TEG) Is a reflection of the dynamic changes in blood coagulation (including the formation rate of fibrin, the dissolution of the state and the consistency of the solid, elastic degree) of the index: R time is the latency of the first fibrin plaque formation. K time is to assess the rate at which blood clots reach a certain level. The alpha angle is similar to the K time, but is more comprehensive than the K time, and is not affected by the low coagulation state. MA reflects the maximum amplitude of blood clots. CI is an integrated coagulation index.TPI is the index of platelet kinetics	Change from base line on the tenth day	No
Secondary	Change of symptom score of the Seattle Angina Questionnaiire(SAQ)	SAQ includes 5 dimensions: the degree of physical activity limitation, the stable state of angina pectoris, the frequency of angina attack, the degree of treatment satisfaction, and the recognition of the disease	Change from base line on the tenth day	No
Secondary	Change of ECG abnormalities	ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris	Change from base line on the tenth day	No
Secondary	Change of score of Traditional Chinese Medicine(TCM) symptom curative effect rating scale	It includes the description of scores of symptoms, signs of tongue and pulse related to blood stasis syndrome of diagnosis of traditional Chinese medicine	Change from base line on the tenth day	No
Secondary	Change of platelet aggregation measured by light transmittance aggregometry(LTA)	The method is widely recognized, and is even considered a gold standard	Change from base line on the tenth day	No
Secondary	Change of serum lipids(TC?TG?HDL-C?LDL-C)	Hyperlipidemia is one of the causes of angina. The measurement units of four indicators(TC?TG?HDL-C?LDL-C)are "mmol/L"	Change from base line on the tenth day	No
Secondary	Change of fasting blood glucose	It is one of the causes of angina(especially for patients with diabetes).The measurement unit is "mmol/L"	Change from base line on the tenth day	No
Secondary	The blood concentration of magnesium lithospermate B	Population pharmacokinetics test is in order to study the relationship between the population pharmacokinetics and clinical outcome. Magnesium lithospermate B is the main effective components of Salvianolate injection.The detection of the blood concentration of magnesium lithospermate B from both salvianolate injection group and salvianolate injection and aspirin group is necessary.	At the discretional two time points from the time point after treatment(0h,0.25h(15min),0.5h,0.75h(45min),1h,1.17h(70min),1.33h(80min),1.67h(100min),2h,2.5h,3h,4h,5h,7h,9h,13h,25h)	No
Secondary	The blood concentration of salicylic acid	Population pharmacokinetics test is in order to study the relationship between the population pharmacokinetics and clinical outcome. Salicylic acid is a kind of metabolite of aspirin. The detection of the blood concentration of salicylic acid from both aspirin group and salvianolate injection and aspirin group is necessary.	At the discretional two time points from the time point after treatment(0h,0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,9h,10h,12h)	No