Back to results

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

Primary Purpose

Stable Angina

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Genotyping

Phenotyping

About this trial

This is an interventional prevention trial for Stable Angina focused on measuring clopidogrel, prasugrel, platelet function testing, genotyping, peri-procedural MI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Heart Center Balatonfüred
1st Department of Cardiology, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Genotyping Arm

Phenotying Arm

Conventional Arm

Arm Description

Rapid genotyping to select optimal P2Y12-inhibitor for PCI.

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

Regular approach for performing elective PCI.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients having periprocedural myocardial infarction (MI)

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.

Full Information

NCT ID

NCT01930773

First Posted

August 25, 2013

Last Updated

December 21, 2018

Sponsor

Medical University of Warsaw

Collaborators

Polish Cardiac Society, University of Pecs

1. Study Identification

Unique Protocol Identification Number

NCT01930773

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Warsaw

Collaborators

Polish Cardiac Society, University of Pecs

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Angina

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Genotyping Arm

Arm Type

Experimental

Arm Description

Rapid genotyping to select optimal P2Y12-inhibitor for PCI.

Arm Title

Phenotying Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional Arm

Arm Type

No Intervention

Arm Description

Regular approach for performing elective PCI.

Intervention Type

Device

Intervention Name(s)

Genotyping

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Phenotyping

Other Intervention Name(s)

VerifyNow P2Y12 assay to test the response to clopidogrel.

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevalence of periprocedural myocardial injury within 24 h after PCI

Description

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

Time Frame

Within 24 hours after Percutaneous Coronary Intervention (PCI)

Secondary Outcome Measure Information:

Title

Proportion of patients having periprocedural myocardial infarction (MI)

Description

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.

Time Frame

Within 24 hours or PCI

Other Pre-specified Outcome Measures:

Title

Peak troponin elevation

Description

The level of peak troponin-I elevation during 24 hours of elective PCI

Time Frame

Within 24 hours of PCI

Title

Proportion of patients with peri-procedural MI

Description

The rate of peri-procedural MI defined as a peak troponin-I value greater than 5x the ULN within 24 hours.

Time Frame

Within 24 hours of PCI

Title

BARC type 3 and 5 bleeding

Description

BARC-defined type 3 (clinical, laboratory, and/or imaging evidence of bleeding, with healthcare provider responses) and type 5 (fatal) bleeds happening within 7 days of PCI.

Time Frame

Within 1 week of PCI

Title

Death, MI, stent thrombosis (ST) or urgent repeat revascularization

Description

The rate of cardiac death, myocardial infarction, definite or probable stent thrombosis or urgent repeat revascularization within 30 days of elective PCI.

Time Frame

30 days after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lukasz Koltowski, MD, PhD

lukasz@koltowski.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mariusz Tomaniak, MD

mariusz.tomaniak@interia.pl

Facility Information:

Facility Name

Heart Center Balatonfüred

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

1st Department of Cardiology, Medical University of Warsaw

City

Warsaw

ZIP/Postal Code

02-097

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lukasz Koltowski, MD, PhD

lukasz@koltowski.com

First Name & Middle Initial & Last Name & Degree

Mariusz Tomaniak, MD

mariusz.tomaniak@interia.pl

First Name & Middle Initial & Last Name & Degree

Lukasz Koltowski, MD

First Name & Middle Initial & Last Name & Degree

Mariusz Tomaniak, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26365936

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.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://www.ncbi.nlm.nih.gov/pubmed/26365936

Available IPD/Information Comments

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). Kołtowski Ł, Aradi D, Huczek Z, Tomaniak M, Sibbing D, Filipiak KJ, Kochman J, Balsam P, Opolski G. Kardiol Pol. 2016;74(4):372-9. doi: 10.5603/KP.a2015.0172.

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

http://www.ncbi.nlm.nih.gov/pubmed/28281736

Available IPD/Information Comments

Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective PCI patients: A pilot study: ONSIDE TEST pilot. Koltowski L, Tomaniak M, Aradi D, Huczek Z, Filipiak KJ, Kochman J, Gajda S, Balsam P, Opolski G. Cardiol J. 2017 Mar 10. doi: 10.5603/CJ.a2017.0026. [Epub ahead of print]

Learn more about this trial

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

We'll reach out to this number within 24 hrs