Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Chunjian Li, Ph.D
        • Sub-Investigator:
          • yuansheng fan, Master
        • Sub-Investigator:
          • xiaoxuan Zhou, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clopidogrel
clopidogrel 75mg qd;aspirin 100mg qd, n=30
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2017

Primary Completion (Anticipated)

April 20, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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