- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330223
Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
January 4, 2018 updated by: The First Affiliated Hospital with Nanjing Medical University
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
Status
Unknown
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Hemolysis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- 008
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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