Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02323971
Status:
UNKNOWN
Last Update Posted:
2017-12-14
First Post:
2014-12-12
Brief Title:
Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients
Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Organization:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study Overview
Official Title:
Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients
Status:
UNKNOWN
Status Verified Date:
2017-12
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:
Ticagrelor
Brief Summary:
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease CAD showing a reduction in adverse events
Detailed Description:
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease CAD showing a reduction in adverse events However there is a considerable number of patients who continue to have recurrent ischemic events despite this regimen In fact in the last years several clinical factors have been associated with impaired clopidogrel-induced effects Moreover these clinical factors are strongly related with the presence of high on-treatment platelet reactivity HPR which is also associated with the occurrence of adverse thrombotic events including stent thrombosis despite correct treatment compliance Diabetes mellitus acute coronary syndromes obesity or chronic kidney disease CKD are common examples This observation encourages the search for new more potent antiplatelet therapies A new P2Y12 receptor antagonist ticagrelor has been approved for clinical use Ticagrelor is a new non-thienopyridine a cyclopentyltriazolo-pyrimidine CPTP direct acting reversible P2Y12 antagonist This compound has a more favorable pharmacokinetic PK and pharmacodynamics PD profile than clopidogrel which has translated into better clinical outcomes in patients with acute coronary syndrome ACS in a recent large international clinical trial Interestingly ticagrelor has showed an impressive clinical benefit in patients with CKD in comparison with those patients without renal impairment
CKD is highly associated with an increased risk of atherothrombotic events including stent thrombosis in patients with CAD PD studies have shown that patients with impaired renal function are characterized by reduced clopidogrel-induced antiplatelet effects and higher rates of HPR compared with patients with preserved renal function
CKD is highly associated with an increased risk of atherothrombotic events including stent thrombosis in patients with CAD PD studies have shown that patients with impaired renal function are characterized by reduced clopidogrel-induced antiplatelet effects and higher rates of HPR compared with patients with preserved renal function
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