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

Not Applicable

Completed

• Conditions: miRNA; PRU
• Interventions: Procedure: miRNA within 24hr; Procedure: miRNA after 1 week; Procedure: miRNA after 1 month

• Registration Number: NCT02101437
• Lead Sponsor: Taipei City Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-02
• Primary Completion: 2014-06
• Status Verified: 2017-04
• Study Completion: 2017-11-01
• Results First Submitted: 2017-11-11
• Results First Submitted QC: 2019-08-23
• Last Update Submitted: 2019-08-23
• Results First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cilostazol	miRNA after 1 month	subjects received cilostazol 100mg bid.
control	miRNA after 1 month	normal subjects.
ticagrelor	miRNA after 1 month	subjects received ticagrelor 90mg qd.
clopidogrel	miRNA after 1 week	subjects received clopidogrel 75mg qd.
ticagrelor	miRNA after 1 week	subjects received ticagrelor 90mg qd.
cilostazol	miRNA after 1 week	subjects received cilostazol 100mg bid.
clopidogrel	miRNA within 24hr	subjects received clopidogrel 75mg qd.
control	miRNA after 1 week	normal subjects.
clopidogrel	miRNA after 1 month	subjects received clopidogrel 75mg qd.
ticagrelor	miRNA within 24hr	subjects received ticagrelor 90mg qd.
cilostazol	miRNA within 24hr	subjects received cilostazol 100mg bid.
control	miRNA within 24hr	normal subjects.

Primary Outcome Measures

Name	Time	Method
miRNA	7 days	miRNA-365-3p measure by Roche miRNA kits; PRP(platelet riched plasma) isolated miRNA by isolation Kit, then havest in cDNA synthesis Kit; then perform RT PCR.; .

Trial Locations

Locations (1)

Taipei city hospital; 🇨🇳 Taipei, Taiwan