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| Name | Class |
|---|---|
| Shenzhen Salubris Pharmaceuticals Co., Ltd. | INDUSTRY |
This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups:
Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day.
Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day.
Platelet inhibition ratio assessment by thrombelastogram will be performed,2 hours after the loading dose(Day 0), 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domestic Clopidogrel 300mg | Experimental | Domestic Clopidogrel 300mg |
|
| Domestic Clopidogrel 600mg | Experimental | Domestic Clopidogrel 600mg |
|
| Imported Clopidogrel 300mg | Experimental | Imported Clopidogrel 300mg |
|
| Imported Clopidogrel 600mg | Active Comparator | Imported Clopidogrel 600mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADP- induced platelet inhibition rate | 2 hours after the loading dose | |
| ADP- induced platelet inhibition rate | 6 hours after the loading dose | |
| ADP- induced platelet inhibition rate | 30 days after the loading dose |
| Measure | Description | Time Frame |
|---|---|---|
| R value (min) | 2 hours after the loading dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yi liu, doctor | Contact | 86-029-84775183 | 1391643423@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| ruining zhang, doctor | Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China | Study Director |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |