NCT02101437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

March 28, 2014

Results QC Date

November 11, 2017

Last Update Submit

August 23, 2019

Conditions

PRUmiRNA

Outcome Measures

Primary Outcomes (1)

  • miRNA

    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. .

    7 days

Study Arms (4)

control

PLACEBO COMPARATOR

normal subjects.

Procedure: miRNA within 24hrProcedure: miRNA after 1 weekProcedure: miRNA after 1 month

clopidogrel

ACTIVE COMPARATOR

subjects received clopidogrel 75mg qd.

Procedure: miRNA within 24hrProcedure: miRNA after 1 weekProcedure: miRNA after 1 month

ticagrelor

ACTIVE COMPARATOR

subjects received ticagrelor 90mg qd.

Procedure: miRNA within 24hrProcedure: miRNA after 1 weekProcedure: miRNA after 1 month

cilostazol

ACTIVE COMPARATOR

subjects received cilostazol 100mg bid.

Procedure: miRNA within 24hrProcedure: miRNA after 1 weekProcedure: miRNA after 1 month

Interventions

miRNA within 24hrPROCEDURE

miRNA within 24hr

cilostazolclopidogrelcontrolticagrelor
miRNA after 1 weekPROCEDURE

miRNA after 1 week

cilostazolclopidogrelcontrolticagrelor
miRNA after 1 monthPROCEDURE

miRNA after 1 month

cilostazolclopidogrelcontrolticagrelor

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • under DAPT (dual antiplatelet therapy) of stable angina patients for elective stent implantation.
  • \. DAPT 24 hours after treatment PRU (platelet activity units) values. (Drug unresponsive patients was defined as PRU\> 235).

You may not qualify if:

  • Not suitable for the treatment of patients with DAPT. (Active peptic ulceration or bleeding) 2 patients of aspirin, clopidogrel, ticagrelor, cilostazol medication intolerance.
  • contraindications for aspirin, clopidogrel, ticagrelor, cilostazol drug usage (such as heart failure patients not suitable for use cilostazol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei city hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 30783954DERIVED

Results Point of Contact

Title
chen yueh-chung
Organization
taipei city hospital
chenyuehchung.tw@yahoo.com.tw
88627093600

Study Officials

  • chen yueh chung, chieft

    taipei city hospital cardiovascular section

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of ICU

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 2, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

November 1, 2017

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2017-04

Locations

TW(1)