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
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