Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02618837
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2015-10-29
Brief Title:
Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non ST Elevated acUte Coronary Syndromes With Initial Invasive Indication
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUBIUS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None