Mechanism of Drug-drug Interaction Between Salvianolate Injection and Aspirin

• Status: Unknown status
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Treatments: Aspirin

Criteria

Inclusion Criteria:

1. Meet the diagnostic criteria of coronary heart disease.

2. Meet the diagnostic criteria of stable angina pectoris.

3. Meet the diagnostic criteria of syndrome of blood stasis.

4. Angina in grade I-II according to Canadian cardiovascular society (CCS).

5. It could be enrolled if the subject taking aspirin or salvianolate injection with one month regularly。

6. The subjects were informed and voluntarily signed informed consent.

Exclusion Criteria:

1. Severe heart disease (acute myocardial infarction of acute myocardial infarction in 6 months), severe cardiopulmonary dysfunction (eg: cardiac function II)

2. Poorly controlled hypertension(systolic pressure >160mmHg or diastolic pressure >100mmHg).

3. Diabetics.

4. Severe primary diseases such as liver and renal hematopoietic system damage. Such as:liver function（ALT≥2×ULN、AST≥2×ULN）,kidney function（Cr>1.0×ULN) or nervous and mental disorder.

5. Pregnant, breast-feeding and menstrual women, or women planning pregnancy within 3 months.

6. Subjects who participated in clinical trials in recent 3 months.

7. Subjects who took surgery treatment or had hemorrhagic tendency in recent 4 weeks.

8. Subjects who had drug allergy history or with allergic constitution.

9. Subjects who has mental or physical disorders.

10. Subjects who had bad compliance or is not suitable for this clinical trial by investigator's judgement