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

Study Overview
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Brief Summary
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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.

Official Title
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Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.

Conditions
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Stable Angina

Intervention / Treatment
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* Device: Genotyping
* Device: Phenotyping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotyping Arm<br>Rapid genotyping to select optimal P2Y12-inhibitor for PCI. | Device: Genotyping<br>* Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.<br>* Other names: Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm.;|
| Experimental: Phenotying Arm<br>The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI. | Device: Phenotyping<br>* Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.<br>* Other names: VerifyNow P2Y12 assay to test the response to clopidogrel.;|
| No Intervention: Conventional Arm<br>Regular approach for performing elective PCI. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of periprocedural myocardial injury within 24 h after PCI | Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI | Within 24 hours after Percutaneous Coronary Intervention (PCI) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having periprocedural myocardial infarction (MI) | 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. | Within 24 hours or PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel, prasugrel, platelet function testing, genotyping, peri-procedural MI