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

• Sponsor: Taipei City Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02101437
• Collaborator: (none)
• Enrollment: 175
• Location: 1
• Arms: 4
• Actual Duration (Months): 46
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PRU; miRNA	Procedure: miRNA within 24hr; Procedure: miRNA after 1 week; Procedure: miRNA after 1 month	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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. .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei city hospital	Taipei		Taiwan

Sponsors and Collaborators

• Taipei City Hospital

Investigators

• Principal Investigator: chen yueh chung, chieft, taipei city hospital cardiovascular section

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yueh-Chung, Chen, chief of ICU, Taipei City Hospital
• ClinicalTrials.gov Identifier: NCT02101437
• Other Study ID Numbers: TCHIRB-I021003
• First Posted: Apr 2, 2014
• Last Update Posted: Aug 28, 2019
• Last Verified: Apr 1, 2017

Study Results

Participant Flow

Arm/Group Title	Control	Clopidogrel	Ticagrelor	Clopidogrel+Cilostazol
Arm/Group Description	no stent or anti-platelet drugs	under clopidogrel treatment	under ticagrelor treatment	under clopidogrel and cilostazol treatment
Period Title: Overall Study
STARTED	20	54	52	49
COMPLETED	20	54	52	49
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Control	Clopidogrel	Ticagrelor	Clopidogrel+Cilostazol	Total
Arm/Group Description	no stent or anti-platelet drugs	under clopidogrel treatment	under ticagrelor treatment	under clopidogrel and cilostazol treatment	Total of all reporting groups
Overall Participants	20	54	52	49	175
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	14 70%	18 33.3%	12 23.1%	12 24.5%	56 32%
>=65 years	6 30%	36 66.7%	40 76.9%	37 75.5%	119 68%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.67 (9.81)	66.39 (10.68)	67.99 (13.56)	65.35 (11.55)	66.59 (12.21)
Sex: Female, Male (Count of Participants)
Female	8 40%	16 29.6%	14 26.9%	21 42.9%	59 33.7%
Male	12 60%	38 70.4%	38 73.1%	28 57.1%	116 66.3%
Region of Enrollment (participants) [Number]
Taiwan	20 100%	52 96.3%	54 103.8%	49 100%	175 100%

Outcome Measures

1. Primary Outcome

Title	miRNA
Description	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. .
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Clopidogrel	Ticagrelor	Clopidogrel+Cilostazol
Arm/Group Description	no stent or anti-platelet drugs	under clopidogrel treatment	under ticagrelor treatment	under clopidogrel and cilostazol treatment
Measure Participants	20	54	52	49
Mean (Full Range) [fold of change]	-8.14	-3.46	-7.54	-3.97

Adverse Events

Arm/Group Title	Control		Clopidogrel		Ticagrelor		Clopidogrel+Cilostazol
Arm/Group Description	no stent or anti-platelet drugs		under clopidogrel treatment		under ticagrelor treatment		under clopidogrel and cilostazol treatment
All Cause Mortality
	Control		Clopidogrel		Ticagrelor		Clopidogrel+Cilostazol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/54 (0%)		0/52 (0%)		0/49 (0%)
Serious Adverse Events
	Control		Clopidogrel		Ticagrelor		Clopidogrel+Cilostazol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/54 (0%)		0/52 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Control		Clopidogrel		Ticagrelor		Clopidogrel+Cilostazol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/54 (0%)		0/52 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.