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

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ClinicalTrials.gov Identifier: NCT02459288
Recruitment Status : Unknown
Verified May 2015 by Ping-Yen Liu, National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : June 2, 2015
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Ping-Yen Liu, National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Chronic Kidney Disease End-Stage Renal Disease Drug: Clopidogrel first Drug: Ticagrelor first Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A comParison on Platelet Resistance With Ticagrelor or Standard-Dose Clopidogrel Study Among SeVerE Chronic Kidney Disease/ End-Stage-Renal-Disease Patients With Recent Acute Coronary Syndrome.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Clopidogrel first
Clopidogrel (Plavix) 75 mg qd, 2 weeks; followed with Ticagrelor (Brilinta) 90 mg bd, 2 weeks
Drug: Clopidogrel 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
Other Name: C-T

Experimental: Ticagrelor first
Ticagrelor (Brilinta) 90 mg bd, 2 weeks; followed with Clopidogrel (Plavix) 75 mg qd, 2 weeks
Drug: Ticagrelor first
After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD
Other Name: T-C




Primary Outcome Measures :
  1. platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes [ Time Frame: baseline, 2 weeks and 4 weeks later (compare cross over effect) ]

Secondary Outcome Measures :
  1. Major bleeding events [ Time Frame: 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 Outcome Measures:
  1. Myocardial infarction [ Time Frame: 1 year ]
  2. emergent condition with hospitalization need [ Time Frame: 30 days ]
    Number of subjects with an emergent condition that required hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02459288


Contacts
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Contact: Ping-Yen Liu, MD, PhD. +88662353535 ext 4602 larry@mail.ncku.edu.tw

Locations
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Taiwan
Department of Internal Medicine, National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Ping-Yen Liu, MD, PhD.    +88662353535 ext 4602    larry@mail.ncku.edu.tw   
Sponsors and Collaborators
Ping-Yen Liu
Investigators
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Principal Investigator: Ping-Yen Liu, MD, PhD. National Cheng Kung University
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Responsible Party: Ping-Yen Liu, Attending Physician, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02459288    
Other Study ID Numbers: A-BR-102-085
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015
Keywords provided by Ping-Yen Liu, National Cheng-Kung University Hospital:
Acute coronary syndrome
Chronic kidney disease
End-Stage Renal Disease
eGFR
Ticagrelor
Clopidogrel
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs