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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: placebo; Drug: Tongxinluo

• Registration Number: NCT01721590
• Lead Sponsor: Han Yaling

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Primary Completion: 2013-05
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	placebo	Placebo，3 capsules/time，3times/day for 1 year
Tongxinluo	Tongxinluo	Tongxinluo 3 capsules/time 3times/day for 1 year

Primary Outcome Measures

Name	Time	Method
Platelet reaction unit(PRU) measured by verifyNow	1 month	to measure the rate of HPR(PRU ≤ 235)

Secondary Outcome Measures

Name	Time	Method
Inflammation Marker (hsCRP、CD62P-CD41)	1 month
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
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

Trial Locations

Locations (3)

ShenZhou Hopital Of ShenYang Medical College; 🇨🇳 ShengYang, Liaoning, China

Northern Hospital; 🇨🇳 Shenyang, Liaoning, China

The 463th Hospital Of PLA; 🇨🇳 ShenYang, Liaoning, China