Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease

Study Overview
=================
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.

Official Title
-----------------
Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Tongxinluo
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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 .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo，3 capsules/time，3times/day for 1 year | Drug: placebo<br>* 3 capsules/time，3times/day for 1 year<br>* Other names: placebo capsules;|
| Experimental: Tongxinluo<br>Tongxinluo 3 capsules/time 3times/day for 1 year | Drug: Tongxinluo<br>* Tongxinluo,3 capsules/time 3times/day for 1 year<br>* Other names: Tongxinluo capsule;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reaction unit(PRU) measured by verifyNow | to measure the rate of HPR(PRU ≤ 235) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation Marker (hsCRP、CD62P-CD41) |  | 1 month | 
| Plasma fibrinogen concentration |  | 1 month | 
| Thrombin time |  | 1 month | 
| Prothrombin time |  | 1 month | 
| major adverse cardiovascular events | Including MI,Stroke,target vessel revascularization,and all-cause mortality | 1 year | 
| bleeding event |  | 1 year | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high on-treatment platelet reactivity, Coronary Heart Disease, Tongxinluo