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Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST) (ONSIDE TEST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Łukasz Kołtowski, Medical University of Warsaw.
Recruitment status was:  Recruiting
University of Pecs
Information provided by (Responsible Party):
Łukasz Kołtowski, Medical University of Warsaw Identifier:
First received: August 25, 2013
Last updated: August 29, 2013
Last verified: August 2013
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 Intervention Phase
Stable Angina Device: Genotyping Device: Phenotyping Phase 3

Study Type: Interventional
Study Design: 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.

Further study details as provided by Łukasz Kołtowski, Medical University of Warsaw:

Primary Outcome Measures:
  • Peak creatine kinase muscle brain (CK-MB) elevation [ Time Frame: Within 24 hours after Percutaneous Coronary Intervention (PCI) ]
    The maximum level of CK-MB elevation within 24 hours of elective PCI.

Secondary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01930773

Contact: Lukasz Koltowski, MD
Contact: Daniel Aradi, MD, PhD

Heart Center Balatonfüred Active, not recruiting
Balatonfüred, Hungary, 8230
1st Department of Cardiology, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-097
Contact: Lukasz Koltowski, MD   
Principal Investigator: Lukasz Koltowski, MD         
Sponsors and Collaborators
Medical University of Warsaw
University of Pecs
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Łukasz Kołtowski, Cardiology Researcher, Medical University of Warsaw Identifier: NCT01930773     History of Changes
Other Study ID Numbers: ONSIDE TEST
Klub 30, 2012 ( Other Identifier: Polish Cardiac Society )
Study First Received: August 25, 2013
Last Updated: August 29, 2013

Keywords provided by Łukasz Kołtowski, Medical University of Warsaw:
platelet function testing
peri-procedural MI

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Prasugrel Hydrochloride
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
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017