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| ID | Type | Description | Link |
|---|---|---|---|
| Klub 30, 2012 | Other Identifier | Polish Cardiac Society |
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| Name | Class |
|---|---|
| Polish Cardiac Society | OTHER |
| University of Pecs | OTHER |
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Patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. Economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotyping Arm | Experimental | Rapid genotyping to select optimal P2Y12-inhibitor for PCI. |
|
| Phenotying Arm | Experimental | The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI. |
|
| Conventional Arm | No Intervention | Regular approach for performing elective PCI. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotyping | Device | Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of periprocedural myocardial injury within 24 h after PCI | Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI | Within 24 hours after Percutaneous Coronary Intervention (PCI) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients having periprocedural myocardial infarction (MI) | Periprocedural MI is defined as a CK-MB elevation greater than 3x of the upper limit of norm (ULN) within 24 hours of elective PCI. | Within 24 hours or PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Peak troponin elevation | The level of peak troponin-I elevation during 24 hours of elective PCI | Within 24 hours of PCI |
| Proportion of patients with peri-procedural MI | The rate of peri-procedural MI defined as a peak troponin-I value greater than 5x the ULN within 24 hours. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukasz Koltowski, MD, PhD | Contact | lukasz@koltowski.com | ||
| Mariusz Tomaniak, MD | Contact | mariusz.tomaniak@interia.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Balatonfüred | Active, not recruiting | Balatonfüred | 8230 | Hungary | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26365936 | Derived | Koltowski L, Aradi D, Huczek Z, Tomaniak M, Sibbing D, Filipiak KJ, Kochman J, Balsam P, Opolski G. Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773). Kardiol Pol. 2016;74(4):372-9. doi: 10.5603/KP.a2015.0172. Epub 2015 Sep 14. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D060005 | Genotyping Techniques |
| D016130 | Immunophenotyping |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
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|
| Phenotyping | Device | Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI. |
|
|
| Within 24 hours of PCI |
| BARC type 3 and 5 bleeding | BARC-defined type 3 (clinical, laboratory, and/or imaging evidence of bleeding, with healthcare provider responses) and type 5 (fatal) bleeds happening within 7 days of PCI. | Within 1 week of PCI |
| Death, MI, stent thrombosis (ST) or urgent repeat revascularization | The rate of cardiac death, myocardial infarction, definite or probable stent thrombosis or urgent repeat revascularization within 30 days of elective PCI. | 30 days after PCI |
| 1st Department of Cardiology, Medical University of Warsaw |
| Recruiting |
| Warsaw |
| 02-097 |
| Poland |
|
Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773). Kołtowski Ł, Aradi D, Huczek Z, Tomaniak M, Sibbing D, Filipiak KJ, Kochman J, Balsam P, Opolski G. Kardiol Pol. 2016;74(4):372-9. doi: 10.5603/KP.a2015.0172. |
| Clinical Study Report | View IPD | Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective PCI patients: A pilot study: ONSIDE TEST pilot. Koltowski L, Tomaniak M, Aradi D, Huczek Z, Filipiak KJ, Kochman J, Gajda S, Balsam P, Opolski G. Cardiol J. 2017 Mar 10. doi: 10.5603/CJ.a2017.0026. [Epub ahead of print] |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007158 | Immunologic Techniques |