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

T

Taipei City Hospital

Status

Completed

Conditions

miRNA
PRU

Treatments

Procedure: miRNA after 1 month
Procedure: miRNA after 1 week
Procedure: miRNA within 24hr

Study type

Interventional

Funder types

Other

Identifiers

NCT02101437
TCHIRB-I021003

Details and patient eligibility

About

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.

Enrollment

175 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

  1. 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).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

175 participants in 4 patient groups, including a placebo group

control
Placebo Comparator group
Description:
normal subjects.
Treatment:
Procedure: miRNA after 1 week
Procedure: miRNA after 1 month
Procedure: miRNA within 24hr
clopidogrel
Active Comparator group
Description:
subjects received clopidogrel 75mg qd.
Treatment:
Procedure: miRNA after 1 week
Procedure: miRNA after 1 month
Procedure: miRNA within 24hr
ticagrelor
Active Comparator group
Description:
subjects received ticagrelor 90mg qd.
Treatment:
Procedure: miRNA after 1 week
Procedure: miRNA after 1 month
Procedure: miRNA within 24hr
cilostazol
Active Comparator group
Description:
subjects received cilostazol 100mg bid.
Treatment:
Procedure: miRNA after 1 week
Procedure: miRNA after 1 month
Procedure: miRNA within 24hr

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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