Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02578537
Status:
UNKNOWN
Last Update Posted:
2015-12-11
First Post:
2015-10-15
Brief Title:
COmparison of the Pharmacodynamics and Pharmacokinetics Ticagrelor Versus Clopidogrel in Patients With CKD and NSTE-ACS
Sponsor:
Shenyang Northern Hospital
Organization:
Shenyang Northern Hospital
Study Overview
Official Title:
COmparison of the Pharmacodynamics and Pharmacokinetics of Ticagrelor Versus Clopidogrel in Patients With Chronic Kidney Disease and Non-ST-Elevation Acute Coronary SyndromesOPT-CKD Trial
Status:
UNKNOWN
Status Verified Date:
2015-12
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:
OPT-CKD
Brief Summary:
Ticagrelor a new P2Y12 receptor antagonist achieve faster consistent and higher platelet inhibition than clopidogrel which was considered more noticeable in patients with ACS combining chronic kidney diseaseCKD Nonetheless the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS P2Y12 inhibitor naïve patients with CKD eGFR 60 mlmin173m2 and NSTE-ACS will be enrolled in this single-center prospective randomized parallel-control study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment The primary endpoint was the PRU by Verify Now at 30 days after loading dose
Detailed Description:
Dual antiplatelet therapy with aspirin and clopidogrel has become the standard care in patients with acute coronary syndrome ACS However clopidogrel is being questioned for its insufficient platelet inhibition and residual platelet reactivity especially in patients with impaired renal function Ticagrelor a new P2Y12 receptor antagonist achieve faster consistent and higher platelet inhibition than clopidogrel which was more noticeable in patients with ACS combining chronic kidney diseaseCKD Nonetheless the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS to the best of the investigators knowledge has not been thoroughly studied This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS The potential hypothesis is to evaluate the correlation of platelet inhibition and renal function and CYP2C19 gene type in patients treated by ticagrelor and clopidogrel P2Y12 inhibitor naïve patients with CKD eGFR 60 mlmin173m2 and NSTE-ACS will be enrolled in this single-center prospective randomized parallel study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment The primary endpoint was the PRU by Verify Now at 30 days after loading dose
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