A Phase 4 interventional study of Clopidogrel first and Ticagrelor first in Acute Coronary Syndrome, Chronic Kidney Disease and End-Stage Renal Disease, sponsored by Ping-Yen Liu. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-06-02.
Sponsored by Ping-Yen Liu · Phase 4, Interventional, and Treatment
A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition and safety observation.
Acute coronary syndrome is a high mortality and costly disease. Antiplatelet therapies, including aspirin and P2Y12 antagonist, play important roles at the acute and subacute stage treatment for acute coronary syndrome, especially after coronary stent implantation. Patients with decreased estimated glomerular filtration rate (eGFR) experience higher cardiovascular morbidity and mortality. Clopidogrel, one of P2Y12 receptor antagonists, inhibits the receptor's activation by blocking its interaction with ADP. However, the efficacy of clopidogrel shows substantial variation and residual platelet reactivity, which is related to adverse cardiovascular outcome, especially in impaired renal function. Our study aims to check the platelet inhibition rate comparing both medication with a cross-over study among CKD subjects and ACS condition.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with Ping-Yen Liu as lead sponsor.
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Exclusion Criteria:
Clopidogrel (Plavix) 75 mg qd, 2 weeks; followed with Ticagrelor (Brilinta) 90 mg bd, 2 weeks
Drug: Clopidogrel first
Ticagrelor (Brilinta) 90 mg bd, 2 weeks; followed with Clopidogrel (Plavix) 75 mg qd, 2 weeks
Drug: Ticagrelor first
After randomization, 2 weeks Clopidogrel (Plavix) 75 mg QD will be given and then crossover with following 2 weeks Ticagrelor (Brilinta) 90 mg bd
Also known as: C-T
After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD
Also known as: T-C
platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes
Time frame: baseline, 2 weeks and 4 weeks later (compare cross over effect)
Major bleeding events
assessed by TIMI bleeding score: mild, moderate and severe; the transfusion of packed red blood cell amount; decreased count in Hb (\>2.5)
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
emergent condition with hospitalization need
Number of subjects with an emergent condition that required hospitalization
Time frame: 30 days
This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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