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

This study is not yet open for participant recruitment.

Verified November 2012 by Shenyang Northern Hospital

Sponsor:

Information provided by (Responsible Party):

Yaling Han, Shenyang Northern Hospital

ClinicalTrials.gov Identifier:

NCT01721590

First received: November 1, 2012

Last updated: NA

Last verified: November 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 1, 2012

Last Updated Date

November 1, 2012

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Platelet aggregation rate( by VerifyNow) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Inflammation Marker (hsCRP、CD62P-CD41) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
BT、FIB and APTT [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Major Ischemia event [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Including MI、Ischemic Stroke and all-cause mortality
bleeding event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Adverse drug reaction and withdrawal rate [ Time Frame: 1 month ，1 year ] [ Designated as safety issue: Yes ]
Angina recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Traditional Chinese medicine angina symptoms scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Intra-stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 aggregation rate( by VerifyNow) at 30 days.The secondary endpoints include inflammation marker (hsCRP、CD62P-CD41),BT、FIB and APTT at 30 days,and MI、Ischemic Stroke and all-cause mortality 、bleeding events at 1 year.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: Tongxinluo

Tongxinluo

Other Name: Tongxinluo capsule

Study Arm (s)

Placebo Comparator: Conrol
Placebo，3 capsules/time，3times/day for 1 year
Experimental: Tongxinluo
Tongxinluo 3 capsules/time 3times/day for 1 year

Intervention: Drug: Tongxinluo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

February 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 .

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yaling Han, MD

+86-24-23922184

13998847715@qq.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01721590

Other Study ID Numbers ^ICMJE

SYNH-20120929

Has Data Monitoring Committee

Yes

Responsible Party

Yaling Han, Shenyang Northern Hospital

Study Sponsor ^ICMJE

Yaling Han

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yaling Han, Dr

Shenyang Northern Hospital

Information Provided By

Shenyang Northern Hospital

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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