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
  Purpose
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 Intervention Phase
Coronary Artery Disease
Drug: Tongxinluo
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • Platelet reaction unit(PRU) measured by verifyNow [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    to measure the rate of HPR(PRU ≤ 235)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 134
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721590

Locations
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
Investigators
Principal Investigator: Yaling Han, Dr Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Han Yaling, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01721590     History of Changes
Other Study ID Numbers: SYNH-20120929 
Study First Received: November 1, 2012
Last Updated: December 21, 2015
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2016