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

NCT ID: NCT01930773

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stable Angina

Keywords

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clopidogrel prasugrel platelet function testing genotyping peri-procedural MI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Genotyping Arm

Rapid genotyping to select optimal P2Y12-inhibitor for PCI.

Group Type EXPERIMENTAL

Genotyping

Intervention Type DEVICE

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

Phenotying Arm

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

Group Type EXPERIMENTAL

Phenotyping

Intervention Type 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.

Conventional Arm

Regular approach for performing elective PCI.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Genotyping

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

Phenotyping

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

Intervention Type DEVICE

Other Intervention Names

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Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm. VerifyNow P2Y12 assay to test the response to clopidogrel.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polish Cardiac Society

OTHER

Sponsor Role collaborator

University of Pecs

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Łukasz Kołtowski

Cardiology Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart Center Balatonfüred

Balatonfüred, , Hungary

Site Status ACTIVE_NOT_RECRUITING

1st Department of Cardiology, Medical University of Warsaw

Warsaw, , Poland

Site Status RECRUITING

Countries

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Hungary Poland

Central Contacts

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Lukasz Koltowski, MD, PhD

Role: CONTACT

Email: [email protected]

Mariusz Tomaniak, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Lukasz Koltowski, MD, PhD

Role: primary

Mariusz Tomaniak, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 26365936 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Other Identifiers

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Klub 30, 2012

Identifier Type: OTHER

Identifier Source: secondary_id

ONSIDE TEST

Identifier Type: -

Identifier Source: org_study_id