An interventional study of salvianolate injection and Aspirin Tablet in Angina, Stable, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Status unknown. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
The combination of anti-platelet medicine treatment and Chinese traditional medicine (TCM) promoting blood circulation to removing blood stasis is widely used in treatment for cardiovascular disease. However, the material foundation, effective mechanism and drug-drug interaction is still not clear. In order to solve the puzzle of rational use of Joint application by TCM and Western Medicine(WM),investigators conduct a research on mechanism of drug-drug interaction between salvianolate injection and aspirin based on metabolic enzyme and PK-PD model. This clinical trial contain three groups, aspirin group, salvianolate injection group and combination (salvianolate injection+aspirin) group. Investigators collect blood samples at special time points during post-administration.Investigators have already find out the Salvianolate's pharmacokinetic characteristics in vivo and establish the biological sample-testing analysis method in previous research. Depending on these results, this clinical trial aim to explore the pharmacodynamics-pharmacokinetics(PK-PD) characteristics of combination with Salvianolate and aspirin through biomarkers, blood concentration. Finally clarify the TCM and WM material basis and mutual mechanism of drug interaction and guide reasonable clinical prescription.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 18 is below the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
only take aspirin (100mg,qd) orally for 10 days treatment course
Drug: Aspirin Tablet
only inject salvianolate(200mg+5%Glucose Injection 250ml，iv) for 10 days treatment course
Drug: salvianolate injection
take aspirin (100mg,qd) orally and inject salvianolate(200mg+5%Glucose Injection 250ml，iv) for 10 days treatment course
Drug: salvianolate injection · Drug: Aspirin Tablet
The main ingredient of salvianolate injection is salvianolic acid B(SAB) which is extracted from the root of red salvia. Red salvia is used in traditional Chinese Medicine. It could promote blood circulation to removing blood stasis,which is clinically effective in treatment for cardiovascular disease.
Anti-platelet medicine treatment and Chinese traditional medicine (TCM) promoting blood circulation to removing blood stasis is widely used in treatment for cardiovascular disease.
Change of P-selection expression(platelet activation-dependent granule membrane) at different time points.
Use flow cytometric method to detect the P-selection expression on platelet at different time points. Analyse the influence of Asprin/Salvianolate on platelet interaction adhesion during drug concentration-time curves.
Time frame: Getting blood sample before taking medicine in the day 10 and after it in 15min、1h、2h、8h、24h
Change of PAC-1 expression (platelet-associated complement) on the activated platelets at different time points.
Use flow cytometric method to detect the PAC-1 expression on platelet at different time points. Analyse the influence of Asprin/Salvianolate on platelet aggregation during drug concentration-time curves.
Time frame: Getting blood sample before taking medicine in the day 10 and after it in 15min、1h、2h、8h、24h
Change of P2Y12 acceptor expression on platelets at different time points. (P2Y12 acceptor is a receptor for ADP(adenosine diphosphate) and ATP (adenosine triphosphate )coupled to G-proteins that inhibit the adenylyl cyclase second messenger system)
Use flow cytometric method to detect the P2Y12 acceptor expression on platelet at different time points. Analyse the influence of Asprin/Salvianolate on platelets aggregation activated by ADP or ATP during drug concentration-time curves.
Time frame: Getting blood sample before taking medicine in the day 10 and after it in 15min、1h、2h、8h、24h
Change of PDE enzymes（phosphodiesterase）expression on platelet at different time points.
Use ELISA method to detect the PDE enzymes expression at different time points. Analyse the influence of Asprin/Salvianolate on platelets activated by PDE enzymes during drug concentration-time curves.
Time frame: Getting blood sample before taking medicine in the day 10 and after it in 15min、1h、2h、8h、24h
Change of Aspirin esterase activity at different blood concentration of Asprin/Salvianolate
Conduct biological analysis by LC-MS/MS(liquid chromatography tandem mass spectrometry) to detect Aspirin and salicylic aspirin and salicylic acid:CSA/C(ASA+SA).The activity of combination arm and of the asprin arm is compared by t test.
Time frame: Getting blood sample before taking aspirin in day 8 and day 9.In the day 10, getting blood sample before taking aspirin and after taking aspirin in 5min、15min、30min、45min、1h、2h、4h、8h、12h、24h
Change of Catechol-o-methyltransferase (COMT) activity at different blood concentration of Asprin/Salvianolate
COMT activity is the main metabolic enzymes of SAB.Use kit to detect COMT activity .
Time frame: Getting blood sample before injection in day 8 and day 9.In the day 10, getting blood sample before injection and after injection in 5min、15min、30min、45min、1h、2h、4h、8h、12h、24h
No study locations are listed for this record.
Start is estimated for Oct 2017; primary completion for Apr 2018, 6 months later.
Of 65 non-industry interventional studies with no phase under Angina, Stable, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 6 months is below that.
Counting every sponsor, half of 76 studies reached it within 35 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Salvianolate · Aspirin
Xiyuan Hospital of China Academy of Chinese Medical Sciences