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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01721590
First received: November 1, 2012
Last updated: December 21, 2015
Last verified: December 2015

November 1, 2012
December 21, 2015
November 2012
May 2013   (final data collection date for primary outcome measure)
Platelet reaction unit(PRU) measured by verifyNow [ Time Frame: 1 month ] [ Designated as safety issue: No ]
to measure the rate of HPR(PRU ≤ 235)
Platelet aggregation rate( by VerifyNow) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01721590 on ClinicalTrials.gov Archive Site
  • Inflammation Marker (hsCRP、CD62P-CD41) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Plasma fibrinogen concentration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Thrombin time [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Prothrombin time [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • major adverse cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Including MI,Stroke,target vessel revascularization,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 ]
  • 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 ]
Not Provided
Not Provided
 
Tongxinluo Improve High on Clopidogrel Platelet Reactivity 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 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.
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,3 capsules/time 3times/day for 1 year
    Other Name: Tongxinluo capsule
  • Drug: placebo
    3 capsules/time,3times/day for 1 year
    Other Name: placebo capsules
  • Placebo Comparator: Control
    Placebo,3 capsules/time,3times/day for 1 year
    Intervention: Drug: placebo
  • 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.
 
Completed
134
June 2014
May 2013   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01721590
SYNH-20120929
Yes
Not Provided
Not Provided
Han Yaling, Shenyang Northern Hospital
Han Yaling
Not Provided
Principal Investigator: Yaling Han, Dr Shenyang Northern Hospital
Shenyang Northern Hospital
December 2015

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