Back to resultsTongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease (Talent)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tongxinluo
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring high on-treatment platelet reactivity, Coronary Heart Disease, Tongxinluo
Eligibility 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 .
Sites / Locations
- ShenZhou Hopital Of ShenYang Medical College
- The 463th Hospital Of PLA
- Northern Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Tongxinluo
Arm Description
Placebo，3 capsules/time，3times/day for 1 year
Tongxinluo 3 capsules/time 3times/day for 1 year
Outcomes
Primary Outcome Measures
Platelet reaction unit(PRU) measured by verifyNow
to measure the rate of HPR(PRU ≤ 235)
Secondary Outcome Measures
Inflammation Marker (hsCRP、CD62P-CD41)
Plasma fibrinogen concentration
Thrombin time
Prothrombin time
major adverse cardiovascular events
Including MI,Stroke,target vessel revascularization,and all-cause mortality
bleeding event
Adverse drug reaction and withdrawal rate
Angina recurrence
Traditional Chinese medicine angina symptoms scores
Intra-stent thrombosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01721590
Brief Title
Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease
Acronym
Talent
Official Title
Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Yaling
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
high on-treatment platelet reactivity, Coronary Heart Disease, Tongxinluo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo，3 capsules/time，3times/day for 1 year
Arm Title
Tongxinluo
Arm Type
Experimental
Arm Description
Tongxinluo 3 capsules/time 3times/day for 1 year
Intervention Type
Drug
Intervention Name(s)
Tongxinluo
Other Intervention Name(s)
Tongxinluo capsule
Intervention Description
Tongxinluo,3 capsules/time 3times/day for 1 year
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo capsules
Intervention Description
3 capsules/time，3times/day for 1 year
Primary Outcome Measure Information:
Title
Platelet reaction unit(PRU) measured by verifyNow
Description
to measure the rate of HPR(PRU ≤ 235)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Inflammation Marker (hsCRP、CD62P-CD41)
Time Frame
1 month
Title
Plasma fibrinogen concentration
Time Frame
1 month
Title
Thrombin time
Time Frame
1 month
Title
Prothrombin time
Time Frame
1 month
Title
major adverse cardiovascular events
Description
Including MI,Stroke,target vessel revascularization,and all-cause mortality
Time Frame
1 year
Title
bleeding event
Time Frame
1 year
Title
Adverse drug reaction and withdrawal rate
Time Frame
1 month ，1 year
Title
Angina recurrence
Time Frame
1 year
Title
Traditional Chinese medicine angina symptoms scores
Time Frame
1 year
Title
Intra-stent thrombosis
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, Dr
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ShenZhou Hopital Of ShenYang Medical College
City
ShengYang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
The 463th Hospital Of PLA
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Northern Hospital
City
Shenyang
State/Province
Liaoning
Country
China
12. IPD Sharing Statement
Learn more about this trial
Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease
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