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Trial record 77 of 1054 for:    clopidogrel

Plasma and Platelet microRNAs in Clopidogrel Low Response Patients (PPRC)

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ClinicalTrials.gov Identifier: NCT02447809
Recruitment Status : Unknown
Verified February 2016 by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : May 19, 2015
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Brief 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Clopidogrel Drug: acetylsalicylic acid (ASA) Phase 4

Detailed Description:

A multiphase, case-control study was designed to identify plasma and platelet miRNAs as surrogate markers for CLR .

All patients take 300mg loading dose clopidogrel plus 100mg daily ASA and 75mg daily clopidogrel after admission. Patients are recruited after percutaneous coronary intervention (PCI). Light transmittancy aggregation (LTA) in response to 5μM ADP is to measured 5 days after taking the loading dose clopidogrel.Than CLR patients were selected.

In the initial biomarker-screening stage, plasma and platelet samples from 20 CLR patients and 20 controls underwent Solexa sequencing to identify miRNAs that showed significant differences between the CLR cases and matched controls.

Subsequently,we performed a biomarker confirmation analysis with a hydrolysis probe-based RT-qPCR assay to refine the number of plasma and platelet miRNAs in the CLR signature. This analysis was carried out in 2 phases: (a) the biomarker-selection phase, in which plasma and platelet samples from 20 CLR patients and 20 control individuals formed the training set, and (b) the biomarker-validation phase, in which plasma and platelet samples from an additional 80 CLR patients and 80 controls formed the validation set.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Association Between Plasma or Platelet microRNAs and Clopidogrel Low Response and Its Mechanism
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Regular DAPT(IPA≤60%)
ASA and Clopidogrel
Drug: Clopidogrel
(ASA 100mg daily and Clopidogre 75mg daily)* 12 month.
Other Name: Plavix

Drug: acetylsalicylic acid (ASA)
Active Comparator: Regular DAPT(IPA>60%)
ASA and Clopidogrel
Drug: Clopidogrel
(ASA 100mg daily and Clopidogre 75mg daily)* 12 month.
Other Name: Plavix

Drug: acetylsalicylic acid (ASA)



Primary Outcome Measures :
  1. The expressions of miRNAs profile [ Time Frame: 5-days After recruited ]
    Two pools of plasma and platelet were collected from participants separately. The total RNA of each pool was extracted by using Trizol Reagent. An initial screening of miRNAs expression was performed by Solexa sequencing. And differential expression was validated using RT-qPCR in individuals samples.


Secondary Outcome Measures :
  1. Clinical efficacy [ Time Frame: 1-month and 1-year after recruited ]
    1-month and 1-year death,non-fatal myocardial infarction,ischemic stroke,revascularization and stent thrombosis(ARC definition)


Other Outcome Measures:
  1. Bleeding [ Time Frame: 1-month and 1-year after recruited ]
    1-month and 1-year minor,moderate and major bleeding



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who receive stent implantation;
  • Patients who take 100mg daily ASA and 75mg daily clopidogrel
  • Patient age >18 years and <80 years old;
  • Signed inform consent

Exclusion Criteria:

  • Allergy or intolerance to ASA,clopidogrel;
  • Patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects of ASA,clopidogrel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447809


Contacts
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Contact: Chunjian Li, Ph.D +86-25-83718836 ext 6018 lijay@njmu.edu.cn
Contact: Hui Zhu +86-25-83718836 ext 6018 zhuhui90@hotmail.com

Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Fuming Zhang, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Contact: Yi Chai, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
National Natural Science Foundation of China
Investigators
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Principal Investigator: Chunjian Li The First Affiliated Hospital with Nanjing Medical University

Publications:

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Responsible Party: Chunjian Li, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02447809     History of Changes
Other Study ID Numbers: 004
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Keywords provided by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University:
microRNA
Platelet
Clopidogrel low response
Additional relevant MeSH terms:
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Clopidogrel
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics