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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01721590
Recruitment Status : Completed
First Posted : November 5, 2012
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Tongxinluo Drug: placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

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 Name: 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 Name: Tongxinluo capsule

Primary Outcome Measures :
  1. Platelet reaction unit(PRU) measured by verifyNow [ Time Frame: 1 month ]
    to measure the rate of HPR(PRU ≤ 235)

Secondary Outcome Measures :
  1. Inflammation Marker (hsCRP、CD62P-CD41) [ Time Frame: 1 month ]
  2. Plasma fibrinogen concentration [ Time Frame: 1 month ]
  3. Thrombin time [ Time Frame: 1 month ]
  4. Prothrombin time [ Time Frame: 1 month ]
  5. major adverse cardiovascular events [ Time Frame: 1 year ]
    Including MI,Stroke,target vessel revascularization,and all-cause mortality

  6. bleeding event [ Time Frame: 1 year ]
  7. Adverse drug reaction and withdrawal rate [ Time Frame: 1 month ,1 year ]
  8. Angina recurrence [ Time Frame: 1 year ]
  9. Traditional Chinese medicine angina symptoms scores [ Time Frame: 1 year ]
  10. Intra-stent thrombosis [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01721590

China, Liaoning
ShenZhou Hopital Of ShenYang Medical College
ShengYang, Liaoning, China, 110032
The 463th Hospital Of PLA
ShenYang, Liaoning, China, 110042
Northern Hospital
Shenyang, Liaoning, China
Sponsors and Collaborators
Han Yaling
Principal Investigator: Yaling Han, Dr Shenyang Northern Hospital

Responsible Party: Han Yaling, vice president, Shenyang Northern Hospital Identifier: NCT01721590     History of Changes
Other Study ID Numbers: SYNH-20120929
First Posted: November 5, 2012    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Keywords provided by Han Yaling, Shenyang Northern Hospital:
high on-treatment platelet reactivity
Coronary Heart Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs