Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST) (ONSIDE TEST)
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ClinicalTrials.gov Identifier: NCT01930773 |
Recruitment Status : Unknown
Verified December 2018 by Łukasz Kołtowski, Medical University of Warsaw.
Recruitment status was: Recruiting
First Posted : August 29, 2013
Last Update Posted : December 24, 2018
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Condition or disease | Intervention/treatment | Phase |
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Stable Angina | Device: Genotyping Device: Phenotyping | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention. |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | March 2019 |
Estimated Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Genotyping Arm
Rapid genotyping to select optimal P2Y12-inhibitor for PCI.
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Device: Genotyping
Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.
Other Name: Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm. |
Experimental: Phenotying Arm
The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI.
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Device: Phenotyping
Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.
Other Name: VerifyNow P2Y12 assay to test the response to clopidogrel. |
No Intervention: Conventional Arm
Regular approach for performing elective PCI.
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- Prevalence of periprocedural myocardial injury within 24 h after PCI [ Time Frame: Within 24 hours after Percutaneous Coronary Intervention (PCI) ]Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI
- Proportion of patients having periprocedural myocardial infarction (MI) [ Time Frame: Within 24 hours or PCI ]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.
- Peak troponin elevation [ Time Frame: Within 24 hours of PCI ]The level of peak troponin-I elevation during 24 hours of elective PCI
- Proportion of patients with peri-procedural MI [ Time Frame: Within 24 hours of PCI ]The rate of peri-procedural MI defined as a peak troponin-I value greater than 5x the ULN within 24 hours.
- BARC type 3 and 5 bleeding [ Time Frame: Within 1 week of PCI ]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.
- Death, MI, stent thrombosis (ST) or urgent repeat revascularization [ Time Frame: 30 days after PCI ]The rate of cardiac death, myocardial infarction, definite or probable stent thrombosis or urgent repeat revascularization within 30 days of elective PCI.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18-75
- elective PCI
Exclusion Criteria:
- acute coronary syndrome (troponin > 1 x ULN),
- administration of glycoprotein IIb/IIIa inhibitors,
- chronic total occlusion,
- lesions with extensive calcifications requiring rotational atherectomy,
- platelet count <70 000 /µl
- high bleeding risk,
- coronary bypass surgery in the previous 3 months,
- severe chronic renal failure (eGFR < 30 mL/min)
- requirement for warfarin, dabigatran, apixaban, rivaroxaban
- history of stroke or TIA,
- weight < 60 kg
- known bleeding diathesis,
- hematocrit of < 30% or >52%
- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930773
Contact: Lukasz Koltowski, MD, PhD | lukasz@koltowski.com | ||
Contact: Mariusz Tomaniak, MD | mariusz.tomaniak@interia.pl |
Hungary | |
Heart Center Balatonfüred | Active, not recruiting |
Balatonfüred, Hungary, 8230 | |
Poland | |
1st Department of Cardiology, Medical University of Warsaw | Recruiting |
Warsaw, Poland, 02-097 | |
Contact: Lukasz Koltowski, MD, PhD lukasz@koltowski.com | |
Contact: Mariusz Tomaniak, MD mariusz.tomaniak@interia.pl | |
Principal Investigator: Lukasz Koltowski, MD | |
Sub-Investigator: Mariusz Tomaniak, MD |

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.

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]
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Łukasz Kołtowski, Cardiology Researcher, Medical University of Warsaw |
ClinicalTrials.gov Identifier: | NCT01930773 |
Other Study ID Numbers: |
ONSIDE TEST Klub 30, 2012 ( Other Identifier: Polish Cardiac Society ) |
First Posted: | August 29, 2013 Key Record Dates |
Last Update Posted: | December 24, 2018 |
Last Verified: | December 2018 |
clopidogrel prasugrel platelet function testing genotyping peri-procedural MI |
Angina, Stable Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations |
Clopidogrel Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |