Clinical Study of Combination Therapy for Angina of Coronary Heart Disease With Aspirin and Salvianolate Injection
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 1, 2016
February 1, 2016
10 months
February 14, 2016
February 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change of thromboela-stogram（R time,K time,α 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
Secondary Outcomes (8)
Change of symptom score of the Seattle Angina Questionnaiire(SAQ)
Change from base line on the tenth day
Change of ECG abnormalities
Change from base line on the tenth day
Change of score of Traditional Chinese Medicine(TCM) symptom curative effect rating scale
Change from base line on the tenth day
Change of platelet aggregation measured by light transmittance aggregometry(LTA)
Change from base line on the tenth day
Change of serum lipids（TC、TG、HDL-C、LDL-C）
Change from base line on the tenth day
- +3 more secondary outcomes
Other Outcomes (13)
Change of PT
Change from base line on the tenth day
Adverse events
Change from base line on the tenth day
Change of basic life sign
Change from base line on the tenth day
- +10 more other outcomes
Study Arms (3)
Salvianolate injection group
OTHERSalvianolate injection,intravenously infusion,0.2g/time,once a day;other routine treatment according to the condition of the disease
Aspirin group
ACTIVE COMPARATORAspirin,oral administration method,0.1g/time,once a day;other routine treatment according to the condition of the disease
Salvianolate injection and aspirin group
EXPERIMENTALSalvianolate 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient age 35-75 years old
- Grade II diagnostic criteria for chronic stable angina pectoris
- Diagnostic criteria of blood stasis type
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Academy of Chinese Medical Scienceslead
- Xiyuan Hospital of China Academy of Chinese Medical Sciencescollaborator
- Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
- General Hospital of Beijing PLA Military Regioncollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
Study Sites (1)
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
Related Publications (1)
Lyu J, Xue M, Li J, Lyu W, Wen Z, Yao P, Li J, Zhang Y, Gong Y, Xie Y, Chen K, Wang L, Chai Y. Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial. Phytomedicine. 2021 Jan;81:153419. doi: 10.1016/j.phymed.2020.153419. Epub 2020 Dec 10.
PMID: 33360345DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yanming Xie, Study Chair
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of institute of traditional Chinese medicine (TCM) clinical and basic medical science
Study Record Dates
First Submitted
February 14, 2016
First Posted
March 1, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
March 1, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share