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

This study is currently recruiting participants.
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

August 25, 2013
August 29, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
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.
Peak CK-MB elevation [ Time Frame: Within 24 hours after PCI ] [ Designated as safety issue: No ]
The maximum level of CK-MB elevation within 24 hours of elective PCI.
Complete list of historical versions of study NCT01930773 on ClinicalTrials.gov Archive Site
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.
Proportion of patients having periprocedural 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 ULN within 24 hours of elective PCI.
  • 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.
  • 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, 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.
 
Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)
Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Stable Angina
  • 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.
  • 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.
  • Experimental: Genotyping Arm
    Rapid genotyping to select optimal P2Y12-inhibitor for PCI.
    Intervention: Device: Genotyping
  • Experimental: Phenotying Arm
    The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI.
    Intervention: Device: Phenotyping
  • No Intervention: Conventional Arm
    Regular approach for performing elective PCI.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
May 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Lukasz Koltowski, MD lukasz@koltowski.com
Contact: Daniel Aradi, MD, PhD
Hungary,   Poland
 
NCT01930773
ONSIDE TEST, Klub 30, 2012
No
Łukasz Kołtowski, Medical University of Warsaw
Medical University of Warsaw
University of Pecs
Not Provided
Medical University of Warsaw
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP