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

Phase 3

• Conditions: Stable Angina
• Interventions: Device: Phenotyping; Device: Genotyping

• Registration Number: NCT01930773
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-08-25
• Study First Submitted QC: 2013-08-25
• Study First Posted: 2013-08-29
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24
• Primary Completion: 2019-03
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenotying Arm	Phenotyping	The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI.
Genotyping Arm	Genotyping	Rapid genotyping to select optimal P2Y12-inhibitor for PCI.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients having periprocedural myocardial infarction (MI)	Within 24 hours or PCI	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.

Trial Locations

Locations (2)

Heart Center Balatonfüred; 🇭🇺 Balatonfüred, Hungary

1st Department of Cardiology, Medical University of Warsaw; 🇵🇱 Warsaw, Poland