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

NCT02578537 | Unknown Phase 4

• 1 other identifier: ESR-14-10607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non ST Segment Elevation Acute Coronary Syndrome; Chronic Kidney Disease

Keywords

Ticagrelor; Pharmacokinetics; NSTE-ACS; CKD

Outcome Measures

Primary Outcomes (1)

• PRU assayed by VerifyNow

  30 days after loading does of study drug

Secondary Outcomes (5)

• PRU assayed by VerifyNow

  at the time of pre-dose, and 2 hours, 8 hours, and 24 hours after loading dose of study durg.

• Index of Platelet activity

  at the time of 2 hours, 8 hours, and 24 hours after loading dose of study drug

• Rate of high on-treatment platelet reactivity (HPR)

  at the time of pre-dose, and 2 hours, 8 hours, 24 hours and 30 days after loading dose of study durg.

• Plasma concentration of ticagrelor and clopidogrel

  at 2 hours, 8 hours, and 24 hours after loading dose of study durg.

• Bleeding events

  30 days after loading does of study drug

Study Arms (2)

Ticagrelor group

EXPERIMENTAL

ticagrelor 180mg loading, followed by 90mg bid for 30 days

Drug: Ticagrelor

Clopidogrel group

ACTIVE COMPARATOR

clopidogrel 600mg loading, followed by 75mg/d for 30 days

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

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.

Also known as: Brilinta

Ticagrelor group

Clopidogrel DRUG

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.

Also known as: Plavix

Clopidogrel group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

Shenyang Northern Hospital

Shenyang, Liaoning, 110016, China

RECRUITING

Related Publications (1)

• Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  PMID: 35224730 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yaling Han, MD

  General Hospital of Shenyang Military Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heyang Wang, MD

CONTACT

86-024-28897309; whysmmu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CN (1)