Tongxinluo Improve High on Clopidogrel Platelet Reactivityn Patients With Coronary Heart Disease (Talent)
This study is not yet open for participant recruitment.
Verified November 2012 by Shenyang Northern Hospital
Sponsor:
Yaling Han
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
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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 |
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 aggregation rate( by VerifyNow) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Conrol
Placebo，3 capsules/time，3times/day for 1 year
|
|
|
Experimental: Tongxinluo
Tongxinluo 3 capsules/time 3times/day for 1 year
|
Drug: Tongxinluo
Tongxinluo
Other Name: Tongxinluo capsule
|
Detailed Description:
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721590
Contacts
| Contact: Yaling Han, MD | +86-24-23922184 | 13998847715@qq.com |
Locations
| China, Liaoning | |
| ShenZhou Hopital Of ShenYang Medical College | Not yet recruiting |
| ShengYang, Liaoning, China, 110032 | |
| Contact: Lu Li, MD 13309882525 | |
| Northern Hospital | Not yet recruiting |
| Shenyang, Liaoning, China | |
| Contact: Yaling Han, Dr +86-24-23922184 13998847715@qq.com | |
| Principal Investigator: Yaling Han, MD | |
| Sub-Investigator: Yi Li, MD | |
| Sub-Investigator: Lei Zhang, MBBS | |
| Sub-Investigator: Meiling Ge, MBBS | |
| The 463th Hospital Of PLA | Not yet recruiting |
| ShenYang, Liaoning, China, 110042 | |
| Contact: Hongyun Zang, MD 15309885517 | |
Sponsors and Collaborators
Yaling Han
Investigators
| Principal Investigator: | Yaling Han, Dr | Shenyang Northern Hospital |
More Information
No publications provided
| Responsible Party: | Yaling Han, 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: | November 1, 2012 |
| 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 Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013