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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Placebo,3 capsules/time,3times/day for 1 year |
|
| Tongxinluo | Experimental | Tongxinluo 3 capsules/time 3times/day for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongxinluo | Drug | Tongxinluo,3 capsules/time 3times/day for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reaction unit(PRU) measured by verifyNow | to measure the rate of HPR(PRU ≤ 235) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation Marker (hsCRP、CD62P-CD41) | 1 month | |
| Plasma fibrinogen concentration | 1 month | |
| Thrombin time |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, Dr | Shenyang Northern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShenZhou Hopital Of ShenYang Medical College | ShengYang | Liaoning | 110032 | China | ||
| The 463th Hospital Of PLA |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| C513941 | tongxinluo |
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| placebo | Drug | 3 capsules/time,3times/day for 1 year |
|
|
| 1 month |
| Prothrombin time | 1 month |
| major adverse cardiovascular events | Including MI,Stroke,target vessel revascularization,and all-cause mortality | 1 year |
| bleeding event | 1 year |
| Adverse drug reaction and withdrawal rate | 1 month ,1 year |
| Angina recurrence | 1 year |
| Traditional Chinese medicine angina symptoms scores | 1 year |
| Intra-stent thrombosis | 1 year |
| Shenyang |
| Liaoning |
| 110042 |
| China |
| Northern Hospital | Shenyang | Liaoning | China |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |