TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome. (TROUPER)
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|ClinicalTrials.gov Identifier: NCT03357874|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : April 11, 2018
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 ml/min) 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 (8-9).Indeed, 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 (3,14-16). 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 drug(EMEA/H/C/1241 (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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: Clopidogrel Drug: Ticagrelor||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||514 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome.|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||August 2021|
|Experimental: Clopidogrel group||
600 mg loading dose of clopidogrel as pretreatment followed by 75 mg daily for 12 months (52 weeks).
|Experimental: Ticagrelor group||
patients will receive a 180 mg loading dose as pretreatment of PCI followed by 90 mg bi-daily for 12 months (52 weeks).
- the rate of major adverse cardiovascular events [ Time Frame: 12 MONTHS ]
- the rate of bleedings [ Time Frame: 1 MONTH AND 12MONTHS ]using the Bleeding Academic Research Consortium classification ≥3 defined at discharge
- the rate of myocardial infarction at discharge [ Time Frame: 1 MONTH AND 12MONTHS ]
- the rate of cardiovascular death at discharge [ Time Frame: 1MONTH AND 12 MONTHS ]
- the rate of urgent revascularization at discharge [ Time Frame: 1MONTH AND 12 MONTHS ]
- the rate of all-cause death at discharge [ Time Frame: 1MONTH AND 12 MONTHS ]
- the rate of hospital re-admission [ Time Frame: 1MONTH AND 12 MONTHS ]
- the rate of probable and definite stent thrombosis (ARC definition) at discharge [ Time Frame: 1MONTH AND 12 MONTHS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357874
|Contact: LAURENT BONELLO||33(0)4 91 96 86 email@example.com|
|Marseille, France, 13354|
|Contact: LAURENT BONELLO firstname.lastname@example.org|
|Study Director:||jean -olivier ARNAUD||AP HM|