The Relationship of Platelet Micro-RNA Expression and Platelet Reactivity in Patients Under Clopidogrel or Ticagrelor Treatment

NCT ID: NCT02101437

Last Updated: 2019-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-11-01

Brief Summary

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For acute coronary syndrome patients undergoing cardiac catheterization after stenting, we will give dual antiplatelet drugs (dual antiplatelet agents) therapy, the choice of the basis of medical criteria (clinical guidelines) routine as aspirin + clopidogrel or aspirin + ticagrelor, according to medical guidelines currently no other disposal alternative proposal (unless adverse drug tolerance or bleeding can not be administered); idea of this experiment for acute coronary syndrome or conventional cardiac catheterization after stenting, platelet miRNA expression (miR-96 , miR-200b, miR-495, miR-107) after cardiac catheterization and interventional treatment of clopidogrel or ticagrelor acceptance of platelet reactivity (PRU) correlation values (given clopidogrel or ticagrelor determined by the clinician, the patient follow-up experiment to track only and observation), aims to explore under different platelet reactivity (hyper-reactive or hypo-reactive), their differences in miRNA performance.

Detailed Description

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Conditions

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PRU miRNA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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control

normal subjects.

Group Type PLACEBO_COMPARATOR

miRNA within 24hr

Intervention Type PROCEDURE

miRNA within 24hr

miRNA after 1 week

Intervention Type PROCEDURE

miRNA after 1 week

miRNA after 1 month

Intervention Type PROCEDURE

miRNA after 1 month

clopidogrel

subjects received clopidogrel 75mg qd.

Group Type ACTIVE_COMPARATOR

miRNA within 24hr

Intervention Type PROCEDURE

miRNA within 24hr

miRNA after 1 week

Intervention Type PROCEDURE

miRNA after 1 week

miRNA after 1 month

Intervention Type PROCEDURE

miRNA after 1 month

ticagrelor

subjects received ticagrelor 90mg qd.

Group Type ACTIVE_COMPARATOR

miRNA within 24hr

Intervention Type PROCEDURE

miRNA within 24hr

miRNA after 1 week

Intervention Type PROCEDURE

miRNA after 1 week

miRNA after 1 month

Intervention Type PROCEDURE

miRNA after 1 month

cilostazol

subjects received cilostazol 100mg bid.

Group Type ACTIVE_COMPARATOR

miRNA within 24hr

Intervention Type PROCEDURE

miRNA within 24hr

miRNA after 1 week

Intervention Type PROCEDURE

miRNA after 1 week

miRNA after 1 month

Intervention Type PROCEDURE

miRNA after 1 month

Interventions

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miRNA within 24hr

miRNA within 24hr

Intervention Type PROCEDURE

miRNA after 1 week

miRNA after 1 week

Intervention Type PROCEDURE

miRNA after 1 month

miRNA after 1 month

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1 under DAPT (dual antiplatelet therapy) of stable angina patients for elective stent implantation.

2\. DAPT 24 hours after treatment PRU (platelet activity units) values. (Drug unresponsive patients was defined as PRU\> 235).

Exclusion Criteria

1.Not suitable for the treatment of patients with DAPT. (Active peptic ulceration or bleeding) 2 patients of aspirin, clopidogrel, ticagrelor, cilostazol medication intolerance.

3 contraindications for aspirin, clopidogrel, ticagrelor, cilostazol drug usage (such as heart failure patients not suitable for use cilostazol).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yueh-Chung, Chen

chief of ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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chen yueh chung, chieft

Role: PRINCIPAL_INVESTIGATOR

taipei city hospital cardiovascular section

Locations

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Taipei city hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Chen YC, Lin FY, Lin YW, Cheng SM, Chang CC, Lin RH, Chuang CL, Sheu JS, Chen SM, Tsai CS. Platelet MicroRNA 365-3p Expression Correlates with High On-treatment Platelet Reactivity in Coronary Artery Disease Patients. Cardiovasc Drugs Ther. 2019 Apr;33(2):129-137. doi: 10.1007/s10557-019-06855-3.

Reference Type DERIVED
PMID: 30783954 (View on PubMed)

Other Identifiers

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TCHIRB-I021003

Identifier Type: -

Identifier Source: org_study_id

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