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COmparison of the Pharmacodynamics and Pharmacokinetics Ticagrelor Versus Clopidogrel in Patients With CKD and NSTE-ACS (OPT-CKD)

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ClinicalTrials.gov Identifier: NCT02578537
Recruitment Status : Unknown
Verified December 2015 by Han Yaling, Shenyang Northern Hospital.
Recruitment status was:  Recruiting
First Posted : October 19, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital

Brief Summary:
Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was considered more noticeable in patients with ACS combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS has not been thoroughly studied. This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS. P2Y12 inhibitor naïve patients with CKD (eGFR < 60 ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized, parallel-control study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify Now at 30 days after loading dose.

Condition or disease Intervention/treatment Phase
Non ST Segment Elevation Acute Coronary Syndrome Chronic Kidney Disease Drug: Ticagrelor Drug: Clopidogrel Phase 4

Detailed Description:
Dual antiplatelet therapy with aspirin and clopidogrel has become the standard care in patients with acute coronary syndrome (ACS). However, clopidogrel is being questioned for its insufficient platelet inhibition and residual platelet reactivity, especially in patients with impaired renal function. Ticagrelor, a new P2Y12 receptor antagonist, achieve faster, consistent and higher platelet inhibition than clopidogrel, which was more noticeable in patients with ACS combining chronic kidney disease(CKD). Nonetheless, the pharmacokinetic properties of ticagrelor in the patients with CKD and NSTE-ACS, to the best of the investigators' knowledge, has not been thoroughly studied. This study was designed to provide PK and PD data of ticagrelor compared with clopidogrel, in order to estimate that ticagrelor is superior to clopidogrel in getting better inhibition of platelet in patients with CKD and NSTE-ACS. The potential hypothesis is to evaluate the correlation of platelet inhibition and renal function and CYP2C19 gene type in patients treated by ticagrelor and clopidogrel. P2Y12 inhibitor naïve patients with CKD (eGFR < 60 ml/min/1.73m2 ) and NSTE-ACS will be enrolled in this single-center, prospective, randomized, parallel study and randomly assigned in a one-to-one ratio to receive ticagrelor or clopidogrel on top of chronic aspirin treatment. The primary endpoint was the PRU by Verify Now at 30 days after loading dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COmparison of the Pharmacodynamics and Pharmacokinetics of Ticagrelor Versus Clopidogrel in Patients With Chronic Kidney Disease and Non-ST-Elevation Acute Coronary Syndromes(OPT-CKD Trial)
Study Start Date : October 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Ticagrelor group
ticagrelor 180mg loading, followed by 90mg bid for 30 days
Drug: Ticagrelor
Ticagrelor group:all patients receive ticagrelor (180 mg loading dose, then 90 mg twice daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred.
Other Name: Brilinta

Active Comparator: Clopidogrel group
clopidogrel 600mg loading, followed by 75mg/d for 30 days
Drug: Clopidogrel
Clopidogrel group:all patients receive clopidogrel (600 mg loading dose, then 75 mg once daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred.
Other Name: Plavix




Primary Outcome Measures :
  1. PRU assayed by VerifyNow [ Time Frame: 30 days after loading does of study drug ]

Secondary Outcome Measures :
  1. PRU assayed by VerifyNow [ Time Frame: at the time of pre-dose, and 2 hours, 8 hours, and 24 hours after loading dose of study durg. ]
  2. Index of Platelet activity [ Time Frame: at the time of 2 hours, 8 hours, and 24 hours after loading dose of study drug ]
    calculated by the change of the P2Y12 reaction units (PRU) from baseline

  3. Rate of high on-treatment platelet reactivity (HPR) [ Time Frame: at the time of pre-dose, and 2 hours, 8 hours, 24 hours and 30 days after loading dose of study durg. ]
  4. Plasma concentration of ticagrelor and clopidogrel [ Time Frame: at 2 hours, 8 hours, and 24 hours after loading dose of study durg. ]
  5. Bleeding events [ Time Frame: 30 days after loading does of study drug ]
    by BARC classification



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • P2Y12 inhibitor naïve patients presenting with NSTE-ACS (unstable angina or non-ST segment elevation myocardial infarction).
  • Males and non-pregnant females > 18 years of age.
  • eGFR<60 ml/min/1.73m2 (MRDR formula).
  • With planned percutaneous coronary intervention(PCI will be performed over 24 hours after loading dose).
  • Written informed consent provided.Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

  • Cardiogenic shock.
  • Thrombolytic therapy administered before randomization.
  • Active bleeding or bleeding predisposition, including the retinal or vitreous hemorrhage , gastrointestinal or urinary tract hemorrhage , history of intracranial haemorrhage or cerebral infarction .
  • Hypersensitivity to ticagrelor or any excipients.
  • Deep puncture or major surgery within 1 month.
  • Untreated or uncontrolled hypertension with blood pressure >180/110 mmHg.
  • Known hemoglobin <10 g/dL or platelet count <100 × 109/L.
  • Known moderate or severe hepatic impairment.
  • Known aminotransferase level >3x the upper limit of normal.
  • Known allergy to any of the study drugs or devices (aspirin, clopidogrel, ticagrelor stainless steel, contrast agents, etc.).
  • Pregnancy or lactation.
  • Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators.
  • Unwilling or unable to get repeat platelet assay or clinical follow-up.
  • Unwilling or unable to provide written informed consent.

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): NCT02578537


Contacts
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Contact: Heyang Wang, MD 86-024-28897309 whysmmu@163.com

Locations
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China, Liaoning
Shenyang Northern Hospital Recruiting
Shenyang, Liaoning, China, 110016
Contact: Yaling Han, MD,PHD    86-024-28856123    hanyaling@263.net   
Contact: Yi Li, MD    86-024-28897309    doctorliyi@126.com   
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
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Principal Investigator: Yaling Han, MD General Hospital of Shenyang Military Region

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Responsible Party: Han Yaling, Dr, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT02578537     History of Changes
Other Study ID Numbers: ESR-14-10607
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Han Yaling, Shenyang Northern Hospital:
Ticagrelor
Pharmacokinetics
NSTE-ACS
CKD
Additional relevant MeSH terms:
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Clopidogrel
Kidney Diseases
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
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