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

Medical University of Warsaw

Status and phase: Unknown; Phase 3

Conditions: Stable Angina

Treatments: Device: Genotyping; Device: Phenotyping

Study type: Interventional

Funder types: Other

Identifiers

NCT01930773

Klub 30, 2012 (Other Identifier)

ONSIDE TEST

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Genotyping Arm

Experimental group

Description:

Rapid genotyping to select optimal P2Y12-inhibitor for PCI.

Treatment:

Device: Genotyping

Phenotying Arm

Experimental group

Description:

The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI.

Treatment:

Device: Phenotyping

Conventional Arm

No Intervention group

Description:

Regular approach for performing elective PCI.