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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | normal subjects. |
|
| clopidogrel | Active Comparator | subjects received clopidogrel 75mg qd. |
|
| ticagrelor | Active Comparator | subjects received ticagrelor 90mg qd. |
|
| cilostazol | Active Comparator | subjects received cilostazol 100mg bid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miRNA within 24hr | Procedure | miRNA within 24hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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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).
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| Name | Affiliation | Role |
|---|---|---|
| chen yueh chung, chieft | taipei city hospital cardiovascular section | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei city hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30783954 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | no stent or anti-platelet drugs |
| FG001 | Clopidogrel | under clopidogrel treatment |
| FG002 | Ticagrelor | under ticagrelor treatment |
| FG003 | Clopidogrel+Cilostazol | under clopidogrel and cilostazol treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
receive different anti-platelet drugs
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | no stent or anti-platelet drugs |
| BG001 | Clopidogrel | under clopidogrel treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. . | 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. | Posted | Mean | Full Range | fold of change | 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | no stent or anti-platelet drugs | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| chen yueh-chung | taipei city hospital | 88627093600 | 3741 | chenyuehchung.tw@yahoo.com.tw |
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| miRNA after 1 week | Procedure | miRNA after 1 week |
|
| miRNA after 1 month | Procedure | miRNA after 1 month |
|
| BG002 |
| Ticagrelor |
under ticagrelor treatment |
| BG003 | Clopidogrel+Cilostazol | under clopidogrel and cilostazol treatment |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Ticagrelor | under ticagrelor treatment |
| OG003 | Clopidogrel+Cilostazol | under clopidogrel and cilostazol treatment |
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Clopidogrel | under clopidogrel treatment | 0 | 54 | 0 | 54 | 0 | 54 |
| EG002 | Ticagrelor | under ticagrelor treatment | 0 | 52 | 0 | 52 | 0 | 52 |
| EG003 | Clopidogrel+Cilostazol | under clopidogrel and cilostazol treatment | 0 | 49 | 0 | 49 | 0 | 49 |
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