Clinical trial NCT01930773: Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)
Official title: Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stable Angina
Keywords: clopidogrel
prasugrel
platelet function testing
genotyping
peri-procedural MI
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Polish Cardiac Society
name: University of Pecs
First posted: 2013-08-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Prevalence of periprocedural myocardial injury within 24 h after PCI
timeFrame: Within 24 hours after Percutaneous Coronary Intervention (PCI)
Secondary outcomes:
measure: Proportion of patients having periprocedural myocardial infarction (MI)
timeFrame: Within 24 hours or PCI
Other outcomes:
measure: Peak troponin elevation
timeFrame: Within 24 hours of PCI
measure: Proportion of patients with peri-procedural MI
timeFrame: Within 24 hours of PCI
measure: BARC type 3 and 5 bleeding
timeFrame: Within 1 week of PCI
measure: Death, MI, stent thrombosis (ST) or urgent repeat revascularization
timeFrame: 30 days after PCI
Locations:
city: Balatonfüred
country: Hungary
facility: Heart Center Balatonfüred
city: Warsaw
country: Poland
facility: 1st Department of Cardiology, Medical University of Warsaw
Study officials:
References:
citation: Koltowski L, Aradi D, Huczek Z, Tomaniak M, Sibbing D, Filipiak KJ, Kochman J, Balsam P, Opolski G. Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773). Kardiol Pol. 2016;74(4):372-9. doi: 10.5603/KP.a2015.0172. Epub 2015 Sep 14.