Clinical trial NCT03330223: Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
Official title: Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure
Coronary Artery Disease
Hemolysis
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents
timeFrame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
Secondary outcomes:
measure: using VerifyNow to detect whether haemodialysis can affect the efficacy of antiplatelet agents
timeFrame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: