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| Name | Class |
|---|---|
| Azienda Ospedaliera di Padova | OTHER |
To evaluate the impact on outcomes of the currently accepted antithrombotic strategies based on the administration of newer P2Y12 receptor blockers (prasugrel and ticagrelor) in a population of non ST elevated ACS (NSTEACS) patients with an initial invasive indication.
Furthermore, to evaluate the effects of bivalirudin administration in comparison to standard therapy with unfractioned heparin (plus provisional anti-GPIIbIIIa) in NSTEACSpatients who undergo PCI and will thus receive these potent antiplatelet agents which may theoretically favor the occurrence of bleedings.
A combined measure of efficacy and safety endpoints, the so-called net clinical benefit (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Downstream strategy arm | Active Comparator | downstream administration strategy of P2Y12 receptor blockers (prasugrel or ticagrelor) |
|
| Upstream strategy arm | Active Comparator | upstream administration strategy (ticagrelor only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Downstream strategy | Procedure | At diagnosis: Subjects receive a loading dose of aspirin (150-300mg). Administration of clopidogrel is allowed only for patients already receiving clopidogrel Pre-procedure: Until PCI is performed, all subjects will be maintained at a minimum of 75mg of aspirin (Subjects with clopidogrel may be maintained at a minimum of 75mg of clopidogrel) Peri- and post-procedure: For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; choice based upon clinical judgement. In this case, subject will be randomized in a 1:1 fashion to prasugrel vs ticagrelor At the time of PCI, the loading doses required (according to randomization):
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of NACE (Net Adverse Cardiac Events) at 30 days | NACE (Net Adverse Cardiac Events) defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding. | 30 days |
| Incidence of NACE (Net Adverse Cardiac Events) at 12 months | NACE (Net Adverse Cardiac Events) defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of single digit and composite of death from vascular causes, MI, stroke, TIA, severe recurrent ischemia, recurrent ischemia, or other arterial thrombotic event. | 30 days, 12 months | |
| Incidence of death from any cause | 30 days, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova | Padova | Veneto | 35131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33234137 | Derived | Tarantini G, Mojoli M, Varbella F, Caporale R, Rigattieri S, Ando G, Cirillo P, Pierini S, Santarelli A, Sganzerla P, De Cesare N, Limbruno U, Lupi A, Ricci R, Cernetti C, Favero L, Saia F, Roncon L, Gasparetto V, Ferlini M, Ronco F, Ferri L, Trabattoni D, Russo A, Guiducci V, Penzo C, Tarantino F, Mauro C, Marchese A, Castiglioni B, La Manna A, Martinato M, Gregori D, Angiolillo DJ, Musumeci G. Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial. Trials. 2020 Nov 24;21(1):966. doi: 10.1186/s13063-020-04859-1. | |
| 32882390 |
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| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Upstream strategy | Procedure | At the time of diagnosis: Subjects randomized in this arm must receive a loading dose of aspirin (150-300 mg) and ticagrelor (180 mg) at admission as soon as possible. Pre-procedure: All subjects will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, until coronary angiography is performed. Peri- and post-procedure: For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; the choice of the anticoagulant at the time of PCI will be based upon clinical judgement. All subjects randomized to the upstream strategy arm will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, for at least 12 months. If the subject develops hypersensitivity or intolerance to ticagrelor, clopidogrel may be used as a substitute at a dose in accordance with standard hospital practice (to be documented in the eCRF). |
|
| Incidence of any stent thrombosis according to the ARC criteria | 30 days, 12 months |
| Incidence of target vessel revascularization (TVR). | 30 days, 12 months |
| Incidence of NACE (Net Adverse Cardiac Events) occurred in the period between admission and coronary revascularization | NACE (Net Adverse Cardiac Events) occurred in the period between admission and coronary revascularization defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 2, 3, 4 and 5 bleeding, | 30 days, 12 months |
| Incidence of target lesion revascularization (TLR) | 30 days, 12 months |
| Incidence of compliance to mandated antiplatelet therapy | 30 days, 12 months |
| Incidence of BARC type 2, 3, 4 and 5 bleeding (single digit and composite). | 30 days, 12 months |
| Incidence of all TIMI major, major-life-threatening, and minor bleeding | 30 days, 12 months |
| Incidence of all CABG surgery-related TIMI major, minor, and composite of TIMI major or minor bleeding | 30 days, 12 months |
| Derived |
| Tarantini G, Mojoli M, Varbella F, Caporale R, Rigattieri S, Ando G, Cirillo P, Pierini S, Santarelli A, Sganzerla P, Cacciavillani L, Babuin L, De Cesare N, Limbruno U, Massoni A, Rognoni A, Pavan D, Belloni F, Cernetti C, Favero L, Saia F, Fovino LN, Masiero G, Roncon L, Gasparetto V, Ferlini M, Ronco F, Rossini R, Canova P, Trabattoni D, Russo A, Guiducci V, Penzo C, Tarantino F, Mauro C, Corrada E, Esposito G, Marchese A, Berti S, Martinato M, Azzolina D, Gregori D, Angiolillo DJ, Musumeci G; DUBIUS Investigators; Italian Society of Interventional Cardiology. Timing of Oral P2Y12 Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Nov 24;76(21):2450-2459. doi: 10.1016/j.jacc.2020.08.053. Epub 2020 Aug 31. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |