Plasma and Platelet microRNAs in Clopidogrel Low Response Patients
NCT02447809 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2016-02-15
Summary
Clopidogrel is an important anti-platelet agent.However, about 30% of the coronary artery disease patients presented clopidogrel low response (CLR).Previous studies showed that the cardiovascular event ratio of the CLR patients was 4.4 times of the normal responders.
It is known that the plasma and platelet miRNAs are determined by different disease status when platelets are released from the megakaryocyte, and the platelet miRNAs can adjust the expressions of the platelet's receptors and proteins.The purpose of this study is to find multiple platelet miRNAs involved in the development of CLR, and platelet miRNAs cause CLR through adjusting the expressions of the key receptors and proteins in the ADP activating pathway and consequently reducing their responses to clopidogrel.
The CLR will be detected by light transmission aggregometry (LTA) and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P). Differential expressions of plasma and platelet miRNAs profile in CLR patients will be screened by deep sequencing and validated to investigate the association between plasma and platelet miRNAs profile and CLR as well as the patients' prognosis.The study results would serve as markers for individualized anti-platelet treatment, and supply new targets for the treatment of coronary artery disease.
Conditions
Interventions
- DRUG
-
Clopidogrel
(ASA 100mg daily and Clopidogre 75mg daily)\* 12 month.
- DRUG
-
acetylsalicylic acid (ASA)
Sponsors & Collaborators
-
National Natural Science Foundation of China
collaborator OTHER_GOV -
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Chunjian Li · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- China
Study Locations
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