Stable AnginaPhase 3ONSIDE TESTNCT01930773
Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)
A Phase 3 study testing Genotyping and Phenotyping in people with Stable Angina, run by Medical University of Warsaw at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- Genotyping and Phenotyping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2013to Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75
- elective PCI
Who cannot join
- 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,
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- 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
Trial locations and contacts
2 sites in 2 countries.
Lukasz Koltowski, MD, PhD contact
Mariusz Tomaniak, MD contact
2 sites in 2 countries
Hungary1 site
- Active, not recruiting
Heart Center Balatonfüred
Balatonfüred, 8230
Poland1 site, 1 recruiting
- Recruiting
1st Department of Cardiology, Medical University of Warsaw
Warsaw, 02-097
Lukasz Koltowski, MD, PhD, lukasz@koltowski.com
Mariusz Tomaniak, MD, mariusz.tomaniak@interia.pl
About this study
Official title: Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.
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
- Being tested
- Genotyping, Phenotyping
- Keywords
- clopidogrel, prasugrel, platelet function testing, genotyping, peri-procedural MI
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingDevice
Also called Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm.
Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.
PhenotypingDevice
Also called VerifyNow P2Y12 assay to test the response to clopidogrel.
Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.
| Study group | Role | What they receive |
|---|---|---|
| Genotyping Arm | Experimental | Rapid genotyping to select optimal P2Y12-inhibitor for PCI. Receives: Device: Genotyping |
| Phenotying Arm | Experimental | The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI. Receives: Device: Phenotyping |
| Conventional Arm | No intervention | Regular approach for performing elective PCI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours after Percutaneous Coronary Intervention (PCI)
Secondary outcomes (1)
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.
Measured: Within 24 hours or PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Cardiac Society, University of Pecs
- Responsible party
- Principal investigator, Łukasz Kołtowski, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930773
- Sponsor's protocol ID
- ONSIDE TEST
- Other IDs
- Klub 30, 2012
- Acronym
- ONSIDE TEST
- Status last verified
- Dec 2018
- First submitted
- 25 Aug 2013
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26365936
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT01930773
- Acronym / sponsor ID
- ONSIDE TEST / ONSIDE TEST
- Conditions
- Stable Angina
- Keywords
- clopidogrel, prasugrel, platelet function testing, genotyping, peri-procedural MI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Polish Cardiac Society, University of Pecs
- Study start
- Mar 2013
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotyping Arm | Experimental | Device: GenotypingRapid genotyping to select optimal P2Y12-inhibitor for PCI. |
| Phenotying Arm | Experimental | Device: PhenotypingThe use of platelet function testing to select the optimal P2Y12-inhibitor for PCI. |
| Conventional Arm | No intervention | –Regular approach for performing elective PCI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-75
- elective PCI
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotypingAlso: Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm.Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel. | Device | Genotyping Arm |
| PhenotypingAlso: VerifyNow P2Y12 assay to test the response to clopidogrel.Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI. | Device | Phenotying Arm |
Primary outcome
Prevalence of periprocedural myocardial injury within 24 h after PCI
Time frame: Within 24 hours after Percutaneous Coronary Intervention (PCI)
Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI
1 secondary outcome
Proportion of patients having periprocedural myocardial infarction (MI)
Time frame: Within 24 hours or PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Derived from this study: PubMed 26365936Koltowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz Koltowski, MD, PhD contact
Mariusz Tomaniak, MD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genotyping and Phenotyping in people with Stable Angina, run by Medical University of Warsaw at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Koltowski, MD, PhD (lukasz@koltowski.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of periprocedural myocardial injury within 24 h after PCI (time frame: Within 24 hours after Percutaneous Coronary Intervention (PCI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.