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

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ClinicalTrials.gov Identifier: NCT02694848
Recruitment Status : Unknown
Verified February 2016 by Xie Yanming, China Academy of Chinese Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Collaborators:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
General Hospital of Beijing PLA Military Region
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Xie Yanming, China Academy of Chinese Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Angina Drug: Salvianolate injection Drug: Aspirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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

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

Experimental: 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
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.




Primary Outcome Measures :
  1. Change of thromboela-stogram(R time,K time,α angle,MA、CI、TPI) [ Time Frame: Change from base line on the tenth day ]
    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


Secondary Outcome Measures :
  1. Change of symptom score of the Seattle Angina Questionnaiire(SAQ) [ Time Frame: Change from base line on the tenth day ]
    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

  2. Change of ECG abnormalities [ Time Frame: Change from base line on the tenth day ]
    ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris

  3. Change of score of Traditional Chinese Medicine(TCM) symptom curative effect rating scale [ Time Frame: Change from base line on the tenth day ]
    It includes the description of scores of symptoms, signs of tongue and pulse related to blood stasis syndrome of diagnosis of traditional Chinese medicine

  4. Change of platelet aggregation measured by light transmittance aggregometry(LTA) [ Time Frame: Change from base line on the tenth day ]
    The method is widely recognized, and is even considered a gold standard

  5. Change of serum lipids(TC、TG、HDL-C、LDL-C) [ Time Frame: Change from base line on the tenth day ]
    Hyperlipidemia is one of the causes of angina. The measurement units of four indicators(TC、TG、HDL-C、LDL-C)are "mmol/L"

  6. Change of fasting blood glucose [ Time Frame: Change from base line on the tenth day ]
    It is one of the causes of angina(especially for patients with diabetes).The measurement unit is "mmol/L"

  7. The blood concentration of magnesium lithospermate B [ Time Frame: 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) ]
    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.

  8. The blood concentration of salicylic acid [ Time Frame: 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) ]
    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.


Other Outcome Measures:
  1. Change of PT [ Time Frame: Change from base line on the tenth day ]
    An index to reflect the status of the extrinsic coagulation system

  2. Adverse events [ Time Frame: Change from base line on the tenth day ]
  3. Change of basic life sign [ Time Frame: Change from base line on the tenth day ]
    In the medical care system, body temperature, blood pressure and pulse are the most important and basic three physiological parameters of the vital signs

  4. Gastrointestinal symptoms [ Time Frame: Change from base line on the tenth day ]
  5. Change of stool routine [ Time Frame: Change from base line on the tenth day ]
    The stool routine includes stool properties, lipid droplets, and white blood cell count

  6. Change of routine blood test [ Time Frame: Change from base line on the tenth day ]
    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

  7. Change of urine routine [ Time Frame: Change from base line on the tenth day ]
    The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar

  8. Change of liver function [ Time Frame: Change from base line on the tenth day ]
    The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase

  9. Change of renal function [ Time Frame: Change from base line on the tenth day ]
    The renal function includes creatinine,usea nitrogen

  10. Change of fecal occult blood [ Time Frame: Change from base line on the tenth day ]
    In order to monitor the safety of the digestive tract (if there is bleeding)

  11. Change of APTT [ Time Frame: Change from base line on the tenth day ]
    An index to reflect the status of endogenous coagulation system

  12. Change of TT [ Time Frame: Change from base line on the tenth day ]
    An index to reflect the time consuming from the fibrinogen into fibrin

  13. Change of FIB [ Time Frame: Change from base line on the tenth day ]
    An index to reflect the content of fibrinogen



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694848


Contacts
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Contact: Lianxin Wang, doctor 86-13521781839 wanglianxin_tcm@126.com
Contact: Junjie Jiang, doctor 86-18910206360 studentjiangjunjie@163.com

Locations
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China, Beijing
Xiyuan Hospital of China Academy of Chinese Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100091
Contact: Keji Chen, Academician    86-13521781839    wlxing@126.com   
Contact: Mei Xue, doctor    86-13581801296    meiar@126.com   
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
General Hospital of Beijing PLA Military Region
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Yanming Xie, Study Chair Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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Responsible Party: Xie Yanming, Director of institute of traditional Chinese medicine (TCM) clinical and basic medical science, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02694848     History of Changes
Other Study ID Numbers: EBM
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Diseases
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics