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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Medical University of Warsaw
Sponsor:
Collaborator:
University of Pecs
Information provided by (Responsible Party):
Łukasz Kołtowski, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01930773
First received: August 25, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01930773

Contacts
Contact: Lukasz Koltowski, MD lukasz@koltowski.com
Contact: Daniel Aradi, MD, PhD

Locations
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       lukasz@koltowski.com   
Principal Investigator: Lukasz Koltowski, MD         
Sponsors and Collaborators
Medical University of Warsaw
University of Pecs
  More Information

No publications provided

Responsible Party: Łukasz Kołtowski, Cardiology Researcher, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01930773     History of Changes
Other Study ID Numbers: ONSIDE TEST, Klub 30, 2012
Study First Received: August 25, 2013
Last Updated: August 29, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
clopidogrel
prasugrel
platelet function testing
genotyping
peri-procedural MI

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014