Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B/P vs A/C for STEMI | Registry Identifier | Milan STEMI registry | |
| Biva/Pra versus Abcix/clop | Registry Identifier | Biva/Pra versus Abcix/clop | |
| Biva/Pra versus Abcix/clop | Registry Identifier | Milan STEMI registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centro Cardiologico Monzino | OTHER |
| Azienda Ospedaliera Niguarda CÃ Granda | OTHER |
| Istituto Clinico Humanitas | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.
Background:
In the setting of STEMI, adjunctive pharmacological therapy plays a key role in the acute management. Along with the clear benefit of mechanical reperfusion strategies, several drugs showed to be beneficial. On top of clopidogrel, heparins and IIB/IIIa glycoprotein, other drugs have been recently introduced showing encouraging results. These "new" drugs, namely prasugrel and bivalirudin, have only been compared separately.
Primary hypothesis: the combination of prasugrel/bivalirudin is superior to the combination of clopidogrel and heparin/abciximab in terms of net adverse clinical events, i.e. ischemic events plus hemorrhagic events
Setting:
- patients presenting with ST-elevation myocardial infarction undergoing primary PCI
Mechanical reperfusion:
-primary percutaneous coronary intervention
Pharmacological Interventions:
- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin
Follow up:
- 1 year
Measurements:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prasugrel/bivalirudin | Active Comparator | 60 mg loading dose of prasugrel will be followed by maintenance dose of 10mg (or 5mg according to body weight and age). During primary PCI, Bivalirudin will be used as anticoagulant (bolus plus infusion), on a weight-adjusted dose. |
|
| clopidogrel/abciximab | Active Comparator | 600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prasugrel/bivalirudin | Drug | 60mg loading dose followed by 10mg or 5 mg (according to body weight or age)maintenance dose of prasugrel. Bivalirudin during the primary PCI (bolus plus infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiovascular events | Combined outcome of overall death, non fatal MI, major stroke | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| major bleedings | according to TIMI major bleedings definition | 1 year |
| minor bleedings | according to TIMI minor bleedings definition |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Testa, MD, PhD | Contact | +39-3490808660 | luctes@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luca Testa, MD,PhD | Istituto Clinico S. Ambrogio | Principal Investigator |
| Fracensco Bedogni, MD | Istituto Clinico S. Ambrogio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico S. Ambrogio | Milan | 20149 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19249633 | Background | Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4. | |
| 19717185 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| C074619 | bivalirudin |
| D000077144 | Clopidogrel |
| D000077284 | Abciximab |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| clopidogrel/abciximab | Drug | 600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion. |
|
|
| 1 year |
| stent thrombosis | according to ARC definition of probable/definite stent thrombosis | 1 year |
| overall death | 1 year |
| non fatal myocardial infarction | defined according to current guidelines | 1 year |
| ischemic stroke | 1 year |
| Background |
| Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |