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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: placebo; Drug: Tongxinluo

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • ShenYang, Liaoning, China, 110042
      • The 463th Hospital Of PLA
    • ShengYang, Liaoning, China, 110032
      • ShenZhou Hopital Of ShenYang Medical College
    • Shenyang, Liaoning, China
      • Northern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Placebo，3 capsules/time，3times/day for 1 year	Drug: placebo; 3 capsules/time，3times/day for 1 year; Other Names: placebo capsules
Experimental: Tongxinluo; Tongxinluo 3 capsules/time 3times/day for 1 year	Drug: Tongxinluo; Tongxinluo,3 capsules/time 3times/day for 1 year; 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

Collaborators and Investigators

• Sponsor: Han Yaling
• Investigators: Principal Investigator: Yaling Han, Dr, Shenyang Northern Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 1, 2012
• First Posted (Estimate): November 4, 2012

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Coronary Heart Disease; high on-treatment platelet reactivity; Tongxinluo
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SYNH-20120929