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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

November 1, 2012
November 1, 2012
November 2012
January 2014   (final data collection date for primary outcome measure)
Platelet aggregation rate( by VerifyNow) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tongxinluo Improve High on Clopidogrel Platelet Reactivityn Patients With Coronary Heart Disease
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
Drug: Tongxinluo
Tongxinluo
Other Name: Tongxinluo capsule
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
February 2014
January 2014   (final data collection date for primary outcome measure)

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 .
Both
18 Years to 85 Years
No
Contact: Yaling Han, MD +86-24-23922184 13998847715@qq.com
China
 
NCT01721590
SYNH-20120929
Yes
Yaling Han, Shenyang Northern Hospital
Yaling Han
Not Provided
Principal Investigator: Yaling Han, Dr Shenyang Northern Hospital
Shenyang Northern Hospital
November 2012

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