Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01567774
Status:
UNKNOWN
Last Update Posted:
2013-05-06
First Post:
2012-03-29
Brief Title:
Pharmacodynamic Effects of Atorvastatin vs Rosuvastatin on Platelet Reactivity
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Pharmacodynamic Effects of Atorvastatin vs Rosuvastatin on pLatelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual Antiplatelet Therapy
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
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:
PEARL
Brief Summary:
Patients with coronary artery disease CAD are often treated with dual antiplatelet therapy DAT including aspirin and clopidogrel to prevent from recurrent atherothrombotic events
Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel
Atorvastatin and simvastatin are metabolized by CYP3A4 Clin pharmacokinetic 2002 41 343-70 whereas the cytochrome P450 mediated metabolism of rosuvastatin appears to be minimal and principally mediated by the 2C9 isoenzyme with little involvement of CYP3A4 Clin Ther 2003 25 2822-5
Previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet function tests have yielded conflicting results
Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel
Atorvastatin and simvastatin are metabolized by CYP3A4 Clin pharmacokinetic 2002 41 343-70 whereas the cytochrome P450 mediated metabolism of rosuvastatin appears to be minimal and principally mediated by the 2C9 isoenzyme with little involvement of CYP3A4 Clin Ther 2003 25 2822-5
Previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet function tests have yielded conflicting results
Detailed Description:
At least 1 month after starting DAT clopidogrel 75 mg and aspirin 100 mg patients will receive randomly atorvastatin 20 mg day N50 or rosuvastatin 10 mg bid N50 for 30 days until T-1
At this time-point there will be a wash-out period of 15 days after the first treatment with atorvastatin or rosuvastatin in order to avoid any carry-over effect
Afterwards a cross-over will be performed and patients will be switched to the other drug which will be continued for further 30 days until T-2
At this time-point there will be a wash-out period of 15 days after the first treatment with atorvastatin or rosuvastatin in order to avoid any carry-over effect
Afterwards a cross-over will be performed and patients will be switched to the other drug which will be continued for further 30 days until T-2
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