Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)
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.
|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.|
- 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.
- 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.
- 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.
|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)|
Experimental: Genotyping Arm
Rapid genotyping to select optimal P2Y12-inhibitor for PCI.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01930773
|Contact: Lukasz Koltowski, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Lukasz Koltowski, MD|