Clinical trial NCT01721590: Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease
Official title: Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: high on-treatment platelet reactivity
Coronary Heart Disease
Tongxinluo
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: Platelet reaction unit(PRU) measured by verifyNow
timeFrame: 1 month
Secondary outcomes:
measure: Inflammation Marker (hsCRP、CD62P-CD41)
timeFrame: 1 month
measure: Plasma fibrinogen concentration
timeFrame: 1 month
measure: Thrombin time
timeFrame: 1 month
measure: Prothrombin time
timeFrame: 1 month
measure: major adverse cardiovascular events
timeFrame: 1 year
measure: bleeding event
timeFrame: 1 year
measure: Adverse drug reaction and withdrawal rate
timeFrame: 1 month ，1 year
measure: Angina recurrence
timeFrame: 1 year
measure: Traditional Chinese medicine angina symptoms scores
timeFrame: 1 year
measure: Intra-stent thrombosis
timeFrame: 1 year
Other outcomes:
Locations:
city: ShengYang
country: China
facility: ShenZhou Hopital Of ShenYang Medical College
state: Liaoning
city: ShenYang
country: China
facility: The 463th Hospital Of PLA
state: Liaoning
city: Shenyang
country: China
facility: Northern Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, Dr
role: PRINCIPAL_INVESTIGATOR
References: