Trial Outcomes & Findings for The Relationship of Platelet Micro-RNA Expression and Platelet Reactivity in Patients Under Clopidogrel or Ticagrelor Treatment (NCT NCT02101437)

Last Updated: 2019-08-28

Results Overview

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. .

Recruitment status

COMPLETED

Study phase

Target enrollment

175 participants

Primary outcome timeframe

7 days

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Control no stent or anti-platelet drugs	Clopidogrel under clopidogrel treatment	Ticagrelor under ticagrelor treatment	Clopidogrel+Cilostazol under clopidogrel and cilostazol treatment
Overall Study STARTED	20	54	52	49
Overall Study COMPLETED	20	54	52	49
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=20 Participants no stent or anti-platelet drugs	Clopidogrel n=54 Participants under clopidogrel treatment	Ticagrelor n=52 Participants under ticagrelor treatment	Clopidogrel+Cilostazol n=49 Participants under clopidogrel and cilostazol treatment	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	18 Participants n=4 Participants	12 Participants n=27 Participants	12 Participants n=483 Participants	56 Participants n=36 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	36 Participants n=4 Participants	40 Participants n=27 Participants	37 Participants n=483 Participants	119 Participants n=36 Participants
Age, Continuous	66.67 years STANDARD_DEVIATION 9.81 • n=93 Participants	66.39 years STANDARD_DEVIATION 10.68 • n=4 Participants	67.99 years STANDARD_DEVIATION 13.56 • n=27 Participants	65.35 years STANDARD_DEVIATION 11.55 • n=483 Participants	66.59 years STANDARD_DEVIATION 12.21 • n=36 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	16 Participants n=4 Participants	14 Participants n=27 Participants	21 Participants n=483 Participants	59 Participants n=36 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	38 Participants n=4 Participants	38 Participants n=27 Participants	28 Participants n=483 Participants	116 Participants n=36 Participants
Region of Enrollment Taiwan	20 participants n=93 Participants	52 participants n=4 Participants	54 participants n=27 Participants	49 participants n=483 Participants	175 participants n=36 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 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.

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. .

Outcome measures

Outcome measures
Measure	Control n=20 Participants no stent or anti-platelet drugs	Clopidogrel n=54 Participants under clopidogrel treatment	Ticagrelor n=52 Participants under ticagrelor treatment	Clopidogrel+Cilostazol n=49 Participants under clopidogrel and cilostazol treatment
miRNA	-8.14 fold of change Interval -8.48 to -7.61	-3.46 fold of change Interval -5.1 to -0.63	-7.54 fold of change Interval -8.27 to -6.81	-3.97 fold of change Interval -5.26 to -3.62

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clopidogrel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ticagrelor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clopidogrel+Cilostazol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

chen yueh-chung

taipei city hospital

Phone: 88627093600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place