PRUNCT02101437

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

A study testing miRNA within 24hr, miRNA after 1 week and miRNA after 1 month in people with PRU and miRNA, run by Taipei City Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: PRU, miRNA
What is being tested?: miRNA within 24hr, miRNA after 1 week and miRNA after 1 month
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 175 participants
Where: 1 siteTaiwan
Study dates: Jan 2014to 1 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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 locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei city hospital
Taipei

Other trials in Taiwan

About this study

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.

Conditions: PRU, miRNA
Being tested: miRNA within 24hr, miRNA after 1 week, miRNA after 1 month

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

miRNA within 24hrProcedure or surgery
miRNA within 24hr
miRNA after 1 weekProcedure or surgery
miRNA after 1 week
miRNA after 1 monthProcedure or surgery
miRNA after 1 month

Study groups in NCT02101437
Study group	Role	What they receive
control	Placebo comparator	normal subjects. Receives: Procedure: miRNA within 24hr; Procedure: miRNA after 1 week; Procedure: miRNA after 1 month
clopidogrel	Active comparator	subjects received clopidogrel 75mg qd. Receives: Procedure: miRNA within 24hr; Procedure: miRNA after 1 week; Procedure: miRNA after 1 month
ticagrelor	Active comparator	subjects received ticagrelor 90mg qd. Receives: Procedure: miRNA within 24hr; Procedure: miRNA after 1 week; Procedure: miRNA after 1 month
cilostazol	Active comparator	subjects received cilostazol 100mg bid. Receives: Procedure: miRNA within 24hr; Procedure: miRNA after 1 week; Procedure: miRNA after 1 month

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20141 Nov 2017

First posted2 Apr 2014 (estimated)
Study startJan 2014
Primary completionJun 2014
Study completion1 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PRUStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02101437
Sponsor's protocol ID: TCHIRB-I021003
Status last verified: Apr 2017
First submitted: 28 Mar 2014
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30783954

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PRU trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship of Platelet Micro-RNA Expression and Platelet Reactivity in Patients Under Clopidogrel or Ticagrelor Treatment
ClinicalTrials.gov ID: NCT02101437
Acronym / sponsor ID: TCHIRB-I021003
Conditions: PRU, miRNA
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Taipei City HospitalOther government
Study start: Jan 2014 (actual)
Primary completion: Jun 2014 (actual)
Study completion: 1 Nov 2017 (actual)
First posted: 2 Apr 2014 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
control	Placebo comparator	Procedure: miRNA within 24hr, Procedure: miRNA after 1 week, Procedure: miRNA after 1 monthnormal subjects.
clopidogrel	Active comparator	Procedure: miRNA within 24hr, Procedure: miRNA after 1 week, Procedure: miRNA after 1 monthsubjects received clopidogrel 75mg qd.
ticagrelor	Active comparator	Procedure: miRNA within 24hr, Procedure: miRNA after 1 week, Procedure: miRNA after 1 monthsubjects received ticagrelor 90mg qd.
cilostazol	Active comparator	Procedure: miRNA within 24hr, Procedure: miRNA after 1 week, Procedure: miRNA after 1 monthsubjects received cilostazol 100mg bid.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
miRNA within 24hrmiRNA within 24hr	Procedure or surgery	cilostazol, clopidogrel, control, ticagrelor
miRNA after 1 weekmiRNA after 1 week	Procedure or surgery	cilostazol, clopidogrel, control, ticagrelor
miRNA after 1 monthmiRNA after 1 month	Procedure or surgery	cilostazol, clopidogrel, control, ticagrelor

Primary outcome

miRNA
Time frame: 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. .

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	20	20
Clopidogrel	54	54
Ticagrelor	52	52
Clopidogrel+Cilostazol	49	49

Primary outcome: miRNA

Time frame: 7 days. Mean (Full Range). Unit: fold of change

Measure	Control n = 20	Clopidogrel n = 54	Ticagrelor n = 52	Clopidogrel+Cilostazol n = 49
Value	-8.14 (-8.48 to -7.61)	-3.46 (-5.1 to -0.63)	-7.54 (-8.27 to -6.81)	-3.97 (-5.26 to -3.62)

Population analysed: check miRNA expression: Normalized expression level=2 -Ct, which means the more amount of miRNA, the less Ct. Negative valure indicated expression\<1, and calculated after log2; the final was fold change expression of miRNA-365-3p compared to the control sample.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Clopidogrel	0 of 54 (0%)	0 of 54 (0%)	0 of 54
Ticagrelor	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Clopidogrel+Cilostazol	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30783954Chen 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.

Related trials for PRU

Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
Peripheral Arterial Disease (PAD), Amputation
Active, not recruitingObservational study
Frontal EEG in OHCA Feasibility Study
Out-Of-Hospital Cardiac Arrest, BIS
Recruiting
Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

chen yueh chung, chieft principal investigator

taipei city hospital cardiovascular section

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing miRNA within 24hr, miRNA after 1 week and miRNA after 1 month in people with PRU and miRNA, run by Taipei City Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

miRNA (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02101437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.