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

Coronary Artery Disease Clinical Trial

— Talent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721590
• Other study ID #: SYNH-20120929
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2012
• Last updated: December 21, 2015
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Tongxinluo
Tongxinluo,3 capsules/time 3times/day for 1 year
• placebo
3 capsules/time,3times/day for 1 year

Locations

Country	Name	City	State
China	ShenZhou Hopital Of ShenYang Medical College	ShengYang	Liaoning
China	Northern Hospital	Shenyang	Liaoning
China	The 463th Hospital Of PLA	ShenYang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Han Yaling

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reaction unit(PRU) measured by verifyNow	to measure the rate of HPR(PRU = 235)	1 month	No
Secondary	Inflammation Marker (hsCRP?CD62P-CD41)		1 month	No
Secondary	Plasma fibrinogen concentration		1 month	No
Secondary	Thrombin time		1 month	Yes
Secondary	Prothrombin time		1 month	Yes
Secondary	major adverse cardiovascular events	Including MI,Stroke,target vessel revascularization,and all-cause mortality	1 year	No
Secondary	bleeding event		1 year	Yes
Secondary	Adverse drug reaction and withdrawal rate		1 month ,1 year	Yes
Secondary	Angina recurrence		1 year	No
Secondary	Traditional Chinese medicine angina symptoms scores		1 year	No
Secondary	Intra-stent thrombosis		1 year	No