A Phase 4 interventional study of Downstream strategy and Upstream strategy in Unstable Angina or Non ST Elevated Myocardial Infarction, sponsored by University of Padova. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2020-12-02.
Sponsored by University of Padova · Phase 4, Interventional, and Diagnostic
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 2,520 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
downstream administration strategy of P2Y12 receptor blockers (prasugrel or ticagrelor)
Procedure: Downstream strategy
upstream administration strategy (ticagrelor only)
Procedure: Upstream strategy
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): * Ticagrelor 180mg, maintained at 90mg b.i.d. for at least 12 months * Prasugrel 60mg, maintained at a minimum of 75mg of aspirin for at least 12 months plus 10mg of prasugrel\* daily for at least 12 months * If subject is \>75 years old or \<60 kg, daily dose of prasugrel should be 5mg
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 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.
Time frame: 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.
Time frame: 12 months
Incidence of single digit and composite of death from vascular causes, MI, stroke, TIA, severe recurrent ischemia, recurrent ischemia, or other arterial thrombotic event.
Time frame: 30 days, 12 months
Incidence of death from any cause
Time frame: 30 days, 12 months
Incidence of any stent thrombosis according to the ARC criteria
Time frame: 30 days, 12 months
Incidence of target vessel revascularization (TVR).
Time frame: 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,
Time frame: 30 days, 12 months
Incidence of target lesion revascularization (TLR)
Time frame: 30 days, 12 months
Incidence of compliance to mandated antiplatelet therapy
Time frame: 30 days, 12 months
Incidence of BARC type 2, 3, 4 and 5 bleeding (single digit and composite).
Time frame: 30 days, 12 months
Incidence of all TIMI major, major-life-threatening, and minor bleeding
Time frame: 30 days, 12 months
Incidence of all CABG surgery-related TIMI major, minor, and composite of TIMI major or minor bleeding
Time frame: 30 days, 12 months
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University of Padova