Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01465828
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2011-10-28
Brief Title:
Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET GENE Trial
Sponsor:
Gennaro Sardella
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
PhaRmacodynamic Effects of Switching thErapy in paTients With High on Treatment Platelet Reactivity and Genotype Variation High Clopidogrel Dose Versus Prasugrel RESET GENE Trial
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
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:
RESET GENE
Brief Summary:
Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome ACS or percutaneous coronary intervention PCI with drug eluting stents Interindividual variability in platelet response to clopidogrel has been reported with several mechanisms being implicated for high post-clopidogrel treatment PR High on-treatment platelet reactivity HTPR is associated with an increased risk of adverse events after PCI Studies in patients on chronic clopidogrel treatment are scarce mainly in diabetic patients where HTPR is frequently present and independently predictive of adverse events Optimization of platelet inhibition in patients with HTPR by increasing clopidogrel or alternatively by more potent P2Y12 inhibitors is a controversial issue mostly studied in post PCI patients while no data exist to the best of the investigators knowledge in stable patients on chronic clopidogrel treatment Therefore all HTPR patients that will accept to participate will be enrolled will randomize Day 0 in a 11 ratio to either clopidogrel 150 mg a day or prasugrel 10 mg a day until Day 14 post randomization A 14 2 day visit will be performed for PR measurement and safety evaluation with the blood sample being will be obtained 16-18 hours after the last study-drug dose will follow by crossover directly to the alternate therapy for an additional 14 days without an intervening washout period At Day 28 2 patients will return for the clinical and laboratory assessment as did on Day 14 visit
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