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

NCT01930773 | Unknown Phase 3

• 2 other identifiers: ONSIDE TESTKlub 30, 2012
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stable Angina

Keywords

clopidogrel; prasugrel; platelet function testing; genotyping; peri-procedural MI

Outcome Measures

Primary Outcomes (1)

• Prevalence of periprocedural myocardial injury within 24 h after PCI

  Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI

  Within 24 hours after Percutaneous Coronary Intervention (PCI)

Secondary Outcomes (1)

• Proportion of patients having periprocedural myocardial infarction (MI)

  Within 24 hours or PCI

Other Outcomes (4)

• Peak troponin elevation

  Within 24 hours of PCI

• Proportion of patients with peri-procedural MI

  Within 24 hours of PCI

• BARC type 3 and 5 bleeding

  Within 1 week of PCI

Study Arms (3)

Genotyping Arm

EXPERIMENTAL

Rapid genotyping to select optimal P2Y12-inhibitor for PCI.

Device: Genotyping

Phenotying Arm

EXPERIMENTAL

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

Device: Phenotyping

Conventional Arm

NO INTERVENTION

Regular approach for performing elective PCI.

Interventions

Genotyping DEVICE

Patients harboring CYP2C19 \*2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.

Also known as: Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm.

Genotyping Arm

Phenotyping DEVICE

Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.

Also known as: VerifyNow P2Y12 assay to test the response to clopidogrel.

Phenotying Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75
• elective PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Polish Cardiac Society: collaborator
• University of Pecs: collaborator

Study Sites (2)

Heart Center Balatonfüred

Balatonfüred, 8230, Hungary

ACTIVE NOT RECRUITING

1st Department of Cardiology, Medical University of Warsaw

Warsaw, 02-097, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 26365936 DERIVED

MeSH Terms

Conditions

Angina, Stable

Interventions

Genotyping Techniques; Immunophenotyping

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques

Central Study Contacts

Lukasz Koltowski, MD, PhD

CONTACT

lukasz@koltowski.com

Mariusz Tomaniak, MD

CONTACT

mariusz.tomaniak@interia.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Researcher

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: August 29, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

HU (1); PL (1)