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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
Sponsor:
Collaborators:
Polish Cardiac Society
University of Pecs
Information provided by (Responsible Party):
Łukasz Kołtowski, Medical University of Warsaw

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stable Angina Device: Genotyping Device: Phenotyping Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Genotyping Arm
Rapid genotyping to select optimal P2Y12-inhibitor for PCI.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Peak troponin elevation [ Time Frame: Within 24 hours of PCI ]
    The level of peak troponin-I elevation during 24 hours of elective PCI

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lukasz Koltowski, MD, PhD lukasz@koltowski.com
Contact: Mariusz Tomaniak, MD mariusz.tomaniak@interia.pl

Locations
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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         
Sponsors and Collaborators
Medical University of Warsaw
Polish Cardiac Society
University of Pecs
More Information
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Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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  This link exits the ClinicalTrials.gov site

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):

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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
Keywords provided by Łukasz Kołtowski, Medical University of Warsaw:
clopidogrel
prasugrel
platelet function testing
genotyping
peri-procedural MI
Additional relevant MeSH terms:
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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