Coronary Artery Disease
Conditions
Keywords
high on-treatment platelet reactivity, Coronary Heart Disease, Tongxinluo
Brief summary
Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this prospective randomized study,all patients in control group will receive blank placebo ,all patients in test group will receive tongxinluo.All patients will be followed up for one year.
Detailed description
The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events at 1 year.
Interventions
DRUGTongxinluo
Tongxinluo,3 capsules/time 3times/day for 1 year
DRUGplacebo
3 capsules/time，3times/day for 1 year
Sponsors
Han Yaling
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
\- (1)ACS (including unstable angina pectoris, non-ST-segment elevation myocardial infarction and ST-elevation myocardial infarction) （2）Accept at least one coronary stent. （3）The age between18 and 75 . （4）High on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by VerifyNow，PRU≥236）at 24 hr after clopidogrel loading (300 \ 600mg)or 24 hours after PCI. （5）Informed Consent
Exclusion criteria
* （1）Tongxinluo contraindication . （2）Receiving GP IIb / IIIa receptor antagonist treatment （3）Who complicate the known bleeding tendency and blood system diseases. （4）NYHA grade III \ IV （5）Aspirin or clopidogrel allergies （6）Severe liver or kidney dysfunction （7）Pregnancy （8）Cann't accept 30 days supervision and blood proofer. （9）Other serious illness, life expectancy less than 6 months. （10) Planned surgery recently （11) PCI again within 30 days. (12) Mental diseases interfering understanding the informed consent form （13）Accept other drugs or participate in other clinical research at the same time .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet reaction unit(PRU) measured by verifyNow | 1 month | to measure the rate of HPR(PRU ≤ 235) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma fibrinogen concentration | 1 month | — |
| Thrombin time | 1 month | — |
| Prothrombin time | 1 month | — |
| major adverse cardiovascular events | 1 year | Including MI,Stroke,target vessel revascularization,and all-cause mortality |
| Inflammation Marker (hsCRP、CD62P-CD41) | 1 month | — |
| Adverse drug reaction and withdrawal rate | 1 month ，1 year | — |
| Angina recurrence | 1 year | — |
| Traditional Chinese medicine angina symptoms scores | 1 year | — |
| Intra-stent thrombosis | 1 year | — |
| bleeding event | 1 year | — |
Countries
China
Outcome results
None listed