NCT02618837

Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers

Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non ST Elevated acUte Coronary Syndromes With Initial Invasive Indication

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,520 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unstable Angina or Non ST Elevated Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Downstream 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
PROCEDURE	Upstream strategy	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).

Timeline

• Start date: 2015-12-14
• Primary completion: 2021-06-01
• Completion: 2022-08-01
• First posted: 2015-12-01
• Last updated: 2020-12-02

Locations

1 site across 1 country: Italy