Acute Coronary Syndrome, Chronic Kidney Disease, End-Stage Renal Disease
Conditions
Keywords
Acute coronary syndrome, Chronic kidney disease, End-Stage Renal Disease, eGFR, Ticagrelor, Clopidogrel
Brief summary
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.
Detailed description
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.
Interventions
DRUGClopidogrel 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
DRUGTicagrelor first
After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD
Sponsors
Ping-Yen Liu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures 2. Female and male, age between 20-75 years 3. Stage 3-5 chronic kidney disease (eGFR\<60ml/min) patients or ESRD 4. Taking standard treatment dose of clopidogrel (75mg/day) for more than 1 week 5. Patients were eligible for enrollment if they were hospitalized for an acute coronary syndrome, with or without ST-segment elevation, with an onset of symptoms during the past 6 months. 6. For patients who had an acute coronary syndrome without ST-segment elevation, at least two of the following three criteria had to be met: ST-segment changes on electrocardiography, indicating ischemia; a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors (age ≥60 years; previous myocardial infarction or coronary-artery bypass grafting \[CABG\]; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease). 7. For patients who had an acute coronary syndrome with ST-segment elevation, the following two inclusion criteria had to be met: persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block.
Exclusion criteria
1. Oral anticoagulation therapy that cannot be stopped 2. Increased risk of bradycardia 3. Concomitant use of strong CYP3A inhibitor/inducers 4. Unwilling to sign inform consent 5. Allergic or contraindicated to any study medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes | baseline, 2 weeks and 4 weeks later (compare cross over effect) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding events | 1 year | assessed by TIMI bleeding score: mild, moderate and severe; the transfusion of packed red blood cell amount; decreased count in Hb (\>2.5) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 1 year | — |
| emergent condition with hospitalization need | 30 days | Number of subjects with an emergent condition that required hospitalization |
Countries
Taiwan
Contacts
Primary ContactPing-Yen Liu, MD, PhD.
Outcome results
None listed