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| Name | Class |
|---|---|
| University of Roma La Sapienza | OTHER |
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International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents.
Thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.
Aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose heparin | Active Comparator | Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) > 300 sec. during the procedure |
|
| Low-dose heparin | Experimental | Bolus of 50 UI/Kg heparin with a target ACT during the procedure of >200 sec. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose heparin | Drug | Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE + stent thrombosis + major bleeding (TIMI definition) | MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | MACE = death, myocardial infarction, target vessel revascularization | 30 days |
| Major Bleeding | Major bleeding according to TIMI criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Major bleeding according to STEEPLE criteria | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Pasceri, MD | Contact | +39063306 | 2504 | vpasceri@hotmail.com |
| Francesco Pelliccia, MD | Contact | +393483392006 | md4151@mclink.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Pasceri, MD | San Filippo Neri Hospital | Study Chair |
| Francesco Pelliccia, MD | University of Roma La Sapienza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome La Sapienza | Recruiting | Rome | 00161 | Italy |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Standard dose heparin | Drug | Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure. |
|
|
| 30 days |
| Stent thrombosis | Stent thrombosis (definite or probable according to ARC criteria) | 30 days |
| CK-MB increase | Any CK MB increase >3 times upper limit of normal or >50% baseline levels (if baseline levels already >then upper limit of normal) | 30 days |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |