Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

• Conditions: Renal Failure; Hemolysis; Coronary Artery Disease
• Interventions: Device: Clopidogrel group;Ticagrelor group

• Registration Number: NCT03330223
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Study Start: 2017-11-10
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08
• Primary Completion: 2019-04-20
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel group;Ticagrelor group	clopidogrel 75mg qd;aspirin 100mg qd, n=30
Ticagrelor	Clopidogrel group;Ticagrelor group	ticagrelor 90mg bid; aspirin 100mg qd, n=30

Primary Outcome Measures

Name	Time	Method
using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents	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

Name	Time	Method
using VerifyNow to detect whether haemodialysis can affect the efficacy of antiplatelet agents	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

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China