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Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

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ClinicalTrials.gov Identifier: NCT03330223
Recruitment Status : Unknown
Verified September 2017 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  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

Tracking Information
First Submitted Date September 27, 2017
First Posted Date November 6, 2017
Last Update Posted Date January 8, 2018
Actual Study Start Date November 10, 2017
Estimated Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03330223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 30, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
Official Title Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Renal Failure
  • Coronary Artery Disease
  • Hemolysis
Intervention 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.
Study Groups/Cohorts
  • Clopidogrel
    clopidogrel 75mg qd;aspirin 100mg qd, n=30
    Intervention: Device: Clopidogrel group;Ticagrelor group
  • Ticagrelor
    ticagrelor 90mg bid; aspirin 100mg qd, n=30
    Intervention: Device: Clopidogrel group;Ticagrelor group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 30, 2017)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2019
Estimated Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03330223
Other Study ID Numbers 008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party The First Affiliated Hospital with Nanjing Medical University
Study Sponsor The First Affiliated Hospital with Nanjing Medical University
Collaborators Not Provided
Investigators Not Provided
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date September 2017