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The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| half dose tirofiban | Experimental | Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI. |
|
| recommended-dose Tirofiban | Active Comparator | Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI. |
|
| none tirofiban | Placebo Comparator | Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tirofiban | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical events | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings | 1 year |
| any bleedings (BARC class) | including all BARC class (class 1-5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Bin, M.D. | Contact | +86 13500810268 | liubin3333@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Bin, M.D. | Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The sencond hospital of Jilin University | Recruiting | Changchun | Jilin | 130041 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| 30 days |
| Major adverse cardiac and cerebral events (MACCE) | a composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days and 1 year |
| stent thrombosis | by ARC definition | 30 days and 1 year |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |