Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03357874
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2017-11-14
Brief Title:
TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2021-01
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:
TROUPER
Brief Summary:
Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS 2 This drug was associated with a 20 relative reduction in the rate of MACE in ACS patients undergoing PCI compared to clopidogrel This benefit came without any increase in major bleedings compared to clopidogrel 6
In the PLATO trial a limited number of kidney failure patients were included 21 and patients with terminal CKD were excluded A sub-group analysis focused on CKD patients was performed Only 214 patients with CKD below stage 4 creatinine clearance 30 mlmin were included 7 No patient with terminal CKD or undergoing chronic hemodialysis was included
Of importance kidney function impairment is frequent and affects up-to 40 of ACS patients In addition CKD is a powerful independent predictor of ischemic complications during ACS 8-9Indeed CKD patients have a very high risk of MACE following ACS with an odd ratio between 2 and 3 compared to patients with normal kidney function and event rates above 40 at one year follow-up 8-13 Of importance these patients more often have high on-clopidogrel platelet reactivity which was strongly associated with a worse clinical outcome 314-16 In CKD patients HTPR was associated with death after PCI 15 Accordingly ticagrelor which overcomes these limitations of clopidogrel could be associated with a major clinical benefit in severe or terminal CKD patients
Most of ticagrelor and is active metabolites are excreted through the feces Preclinical data suggested that renal impairment had little effect on systemic exposure to the drugEMEAHC1241 28 Recent pharmacodynamic and kinetic studies confirmed these preclinical data on the safety of ticagrelor in severe and end-stage CKD 17-19
Therefore based on the rational above and to the lack of relevant clinical data the optimal P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic dialysis remains undetermined in ACS treated with PCI
We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4 and 5 or on chronic hemodialysis undergoing PCI for ACS
In the PLATO trial a limited number of kidney failure patients were included 21 and patients with terminal CKD were excluded A sub-group analysis focused on CKD patients was performed Only 214 patients with CKD below stage 4 creatinine clearance 30 mlmin were included 7 No patient with terminal CKD or undergoing chronic hemodialysis was included
Of importance kidney function impairment is frequent and affects up-to 40 of ACS patients In addition CKD is a powerful independent predictor of ischemic complications during ACS 8-9Indeed CKD patients have a very high risk of MACE following ACS with an odd ratio between 2 and 3 compared to patients with normal kidney function and event rates above 40 at one year follow-up 8-13 Of importance these patients more often have high on-clopidogrel platelet reactivity which was strongly associated with a worse clinical outcome 314-16 In CKD patients HTPR was associated with death after PCI 15 Accordingly ticagrelor which overcomes these limitations of clopidogrel could be associated with a major clinical benefit in severe or terminal CKD patients
Most of ticagrelor and is active metabolites are excreted through the feces Preclinical data suggested that renal impairment had little effect on systemic exposure to the drugEMEAHC1241 28 Recent pharmacodynamic and kinetic studies confirmed these preclinical data on the safety of ticagrelor in severe and end-stage CKD 17-19
Therefore based on the rational above and to the lack of relevant clinical data the optimal P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic dialysis remains undetermined in ACS treated with PCI
We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4 and 5 or on chronic hemodialysis undergoing PCI for ACS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002839-42 | EUDRACT_NUMBER | None | None |