miRNA, PRU
Conditions
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.
Interventions
PROCEDUREmiRNA within 24hr
miRNA within 24hr
PROCEDUREmiRNA after 1 week
miRNA after 1 week
PROCEDUREmiRNA after 1 month
miRNA after 1 month
Sponsors
Taipei City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. . |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control no stent or anti-platelet drugs | 20 |
| Clopidogrel under clopidogrel treatment | 54 |
| Ticagrelor under ticagrelor treatment | 52 |
| Clopidogrel+Cilostazol under clopidogrel and cilostazol treatment | 49 |
| Total | 175 |
Baseline characteristics
| Characteristic | Clopidogrel | Ticagrelor | Control | Clopidogrel+Cilostazol | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 40 Participants | 6 Participants | 37 Participants | 119 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 12 Participants | 14 Participants | 12 Participants | 56 Participants |
| Age, Continuous | 66.39 years STANDARD_DEVIATION 10.68 | 67.99 years STANDARD_DEVIATION 13.56 | 66.67 years STANDARD_DEVIATION 9.81 | 65.35 years STANDARD_DEVIATION 11.55 | 66.59 years STANDARD_DEVIATION 12.21 |
| Region of Enrollment Taiwan | 52 participants | 54 participants | 20 participants | 49 participants | 175 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 8 Participants | 21 Participants | 59 Participants |
| Sex: Female, Male Male | 38 Participants | 38 Participants | 12 Participants | 28 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 54 | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 0 / 20 | 0 / 54 | 0 / 52 | 0 / 49 |
| serious Total, serious adverse events | 0 / 20 | 0 / 54 | 0 / 52 | 0 / 49 |
Outcome results
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. .
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | miRNA | -8.14 fold of change |
| Clopidogrel | miRNA | -3.46 fold of change |
| Ticagrelor | miRNA | -7.54 fold of change |
| Clopidogrel+Cilostazol | miRNA | -3.97 fold of change |