Downstream versus Upstream strategy for the administration of two antiplatelets in non ST elevated coronary syndrome with initial invasive indication

Downstream versus Upstream strategy for the administration of P2Y12 receptor Blockers In non ST elevated acUte coronary Syndromes with initial invasive indication - DUBIUS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000993-37-IT

Enrollment

2520

Registered

2021-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with non ST elevated acute coronary syndrome (unstable angina, non ST elevated myocardial infarction), with an onset of symptoms during the previous 72 hours with initial invasive indication MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10071111 Term: Non ST segment elevation acute coronary syndrome System Organ Class: 10007541 - Cardiac diso

Interventions

Trade Name: BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 56 COMPRESSE (CONF. CALENDARIZZATA) Product Name: Brilique Pharmaceutical Form: Film-coated tablet Trad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with acute coronary syndromes non ST-segment elevation (NSTEACS) with onset of symptoms during the previous 24 hours and for which the initial invasive strategy is chosen. The subject is able to verbally confirm the understanding of the risks and benefits and provides informed consent signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2020

Exclusion criteria

Exclusion criteria: Platelet count 700,000 cells / mm³, or white blood cell count (WBC) <3,000 cells / mm³ seven days before the procedure. Previous hemorrhagic or ischemic stroke, transient ischemic attack (TIA), or subarachnoid hemorrhage. Receiving a GP IIb / IIIa inhibitor

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine the net clinical benefit of downstream strategy for the administration of newer antiplatelet agents (prasugrel or ticagrelor) versus the upstream strategy (only ticagrelor) in patients with NSTEACS invasive initial indication. Determine the net clinical benefit of prasugrel compared with administration of ticagrelor, within the group of the PCI arm downstream strategy.;Secondary Objective: Determine the net clinical benefit of unfractionated heparin compared to bivalirudin within the entire group PCI.;Primary end point(s): Incidence at 30 days and 12 months of 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.;Timepoint(s) of evaluation of this end point: 30 days and 12 months	—

Measure

Time frame

Main Objective: Determine the net clinical benefit of downstream strategy for the administration of newer antiplatelet agents (prasugrel or ticagrelor) versus the upstream strategy (only ticagrelor) in patients with NSTEACS invasive initial indication. Determine the net clinical benefit of prasugrel compared with administration of ticagrelor, within the group of the PCI arm downstream strategy.;Secondary Objective: Determine the net clinical benefit of unfractionated heparin compared to bivalirudin within the entire group PCI.;Primary end point(s): Incidence at 30 days and 12 months of 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.;Timepoint(s) of evaluation of this end point: 30 days and 12 months

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Countries

Italy

Contacts

Public ContactUOC Cardiologia

Azienda Ospedaliera di Padova

giuseppe.tarantini.1@gmail.com0498211844

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026