Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

Coronary Artery Disease Clinical Trial

Official title:

Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330223
• Other study ID #: 008
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2017
• Last updated: January 4, 2018
• Start date: November 10, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2017
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hemolysis
• Myocardial Ischemia
• Renal Failure
• Renal Insufficiency

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents	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	using VerifyNow to detect whether haemodialysis can affect the efficacy of antiplatelet agents	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