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Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

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ClinicalTrials.gov Identifier: NCT03330223
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The main purpose of our study is to investigate whether haemodialysis itself affects the efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after two times of haemodialysis.

Condition or disease Intervention/treatment
Renal Failure Coronary Artery Disease Hemolysis Device: Clopidogrel group;Ticagrelor group

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clopidogrel
clopidogrel 75mg qd;aspirin 100mg qd, n=30
Device: Clopidogrel group;Ticagrelor group
A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after haemodialysis.

Ticagrelor
ticagrelor 90mg bid; aspirin 100mg qd, n=30
Device: Clopidogrel group;Ticagrelor group
A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after haemodialysis.




Primary Outcome Measures :
  1. using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents [ Time Frame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours ]
    intravenous blood collection with anticoagulant tube before and after haemodialysis respectively ;using light transmittance aggregometer to detect adenosine diphosphate induced platelet aggregation rate and arachidonic acid induced platelet aggregation rate within two hours after blood collection;;compare the outcome of light transmittance aggregometer with VerifyNow


Secondary Outcome Measures :
  1. using VerifyNow to detect whether haemodialysis can affect the efficacy of antiplatelet agents [ Time Frame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours ]
    intravenous blood collection with VeryfiNow to detect the platelet reaction unit before and after haemodialysis respectively



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiovascular events account for about 50% of all-cause mortality in patients with end-stage renal disease(ESRD), and about 20% of cardiac death events are caused by acute coronary syndromes(ACS).Over the past decade, the number of percutaneous coronary intervention (PCI) in patients with ESRD has increased by nearly 50%. Aspirin, clopidogrel and ticagrelor are the most widely used antiplatelet agents in ACS patients after PCI.Little is known about whether hemodialysis can affect the efficacy of antiplatelet agents or not.
Criteria

Inclusion Criteria:

  • diagnosis of coronary heart disease including stable angina, unstable angina, acute myocardial infarction
  • taking dual antiplatelet drugs (clopidogrel 75mg qd + aspirin 100mg qd or ticagrelor 90 mg,bid + aspirin 100 mg,qd) at least 5 days
  • haemodialysis patients
  • sign informed consent

Exclusion Criteria:

  • platelet count>450 × 10 9 /L or <100 × 10 9 /L
  • using IIb / IIIa inhibitor drugs within 10days
  • taking nonsteroidal anti-inflammatory drugs other than aspirin
  • hemorrhagic disease
  • allergic to aspirin, ticagrelor or clopidogrel
  • other factors may affect the results of this study

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): NCT03330223


Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Fuming Zhang, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Contact: Yi Chai, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Principal Investigator: chunjian Li, Ph.D         
Sub-Investigator: yuansheng fan, Master         
Sub-Investigator: xiaoxuan Zhou, Master         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03330223     History of Changes
Other Study ID Numbers: 008
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Hemolysis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Pathologic Processes
Aspirin
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors