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GENIOUS: PPI vs No PPI in Clopidogrel-Treated PCI Patients
NCT01512953Phase 4
Key facts
- Status
- Unknown
- Start
- Jan 2011
- Primary completion
- Aug 2012
- Countries
- 1
- Sponsor
- University of Ferrara
- Modality
- Small Molecules
- Drugs
- lansoprazole
- Conditions
- Gastrointestinal Bleeding (GIB)
01
Overview
Phase 4, randomised, single-blind trial of lansoprazole in Gastrointestinal Bleeding (GIB) (2 arms), sponsored by University of Ferrara. Primary endpoints: Maximal platelet aggregation at light transmission aggregometry after 20 μmol/l ADP at 30 days and Maximal platelet aggregation after 5 μmol/l ADP at 30 days. Status: unknown.
02
Design
2 arms- Study design
- RandomizedSingle-blind
no PPI
Clopidogrel alone
PPI
Lansoprazole + Clopidogrel
03
Who it enrols
Patients undergoing PCI (elective, urgent, or emergent) treated with clopidogrel. Excludes patients with bleeding risk, age > 90, previous stroke, or on coumadin.
04
Endpoints
Primary
Maximal platelet aggregation at light transmission aggregometry after 20 μmol/l ADP
Maximal platelet aggregation after 5 μmol/l ADP
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