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Recruiting NCT02762162

Registry of Coronary Artery Ill Patients With Platelet Test Results

Observational Acute Coronary Syndrome Percutaneous Coronary Intervention Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome, Percutaneous Coronary Intervention, Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Online Assistance for Stent Thrombosis

Overview

ONASSIST is a registry of coronary ill patients who have had a functional test measuring anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.

Detailed description

The Onassist Project is an assistance for cardiologists that establishes an individual risk of stent thrombosis for each patient based on:

* a functional approach (evaluation of the antiplatelet effect of the antiplatelet regimen by multiple tests) and * a pharmacogenomic approach (genetic profile of response to antiplatelet agents) It provides advices for specific therapeutics after identification of adverse drug interactions, treatment compliance issues and true genetic, functional or mixed resistance.

This individualized strategy allow to adjust the choice of the drugs and their optimal dosage considering the best benefit - risk ratio.

Follow up are regularly made to identify markers of MACE (major adverse cardiac event) or bleeding.

Primary outcome measures

  • Bleeding [Time frame: 10 years]
  • Myocardial Infarction [Time frame: 10 years]
  • Death [Time frame: 10 years]
  • Stroke [Time frame: 10 years]
  • Urgent Revascularization [Time frame: 10 years]
  • Resuscitated Cardiac Arrest [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • coronary disease
  • antiplatelets testing performed as part of usual care and / or gentic profile of antiplatelet response done

Exclusion criteria

  • patient refusing to be part of the registry

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hopital Pitie Salpetriere — Paris

Identifiers

NCT: NCT02762162 · ONASSIST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗