Overview

Platelet Resistance With Ticagrelor or Standard-Dose Clopidogrel Among CKD and ACS Patients

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ping-Yen Liu
Treatments:
Clopidogrel
Ticagrelor
Ticlopidine
Criteria
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