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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02101437
Other study ID # TCHIRB-I021003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date November 1, 2017

Study information

Verified date April 2017
Source Taipei City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date November 1, 2017
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Taipei city hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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