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

Information source: Medical University of Warsaw
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stable Angina

Intervention: Genotyping (Device); Phenotyping (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Medical University of Warsaw

Overall contact:
Lukasz Koltowski, MD, Email: lukasz@koltowski.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Peak creatine kinase muscle brain (CK-MB) elevation

Secondary outcome: Proportion of patients having periprocedural myocardial infarction (MI)

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Lukasz Koltowski, MD, Email: lukasz@koltowski.com

Heart Center Balatonfüred, Balatonfüred 8230, Hungary; Active, not recruiting

1st Department of Cardiology, Medical University of Warsaw, Warsaw 02-097, Poland; Recruiting
Lukasz Koltowski, MD, Email: lukasz@koltowski.com
Lukasz Koltowski, MD, Principal Investigator

Additional Information

Starting date: March 2013
Last updated: August 29, 2013

Page last updated: August 20, 2015

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