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NCT Number: NCT02762162

Registry of Coronary Artery Ill Patients With Platelet Test Results

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Pitie Salpetriere

Paris, 75013, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bleeding

    Time frame: 10 years

    all bleeding according to the BARC (Bleeding Academic Research Consortium) definitions are registered during the follow up

  2. Myocardial Infarction

    Time frame: 10 years

  3. Death

    Time frame: 10 years

  4. Stroke

    Time frame: 10 years

  5. Urgent Revascularization

    Time frame: 10 years

  6. Resuscitated Cardiac Arrest

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine Brugier, PhD

CONTACT

[email protected]

+33142162918

Jean Philippe COLLET, MD, PhD

CONTACT

[email protected]

+33142162962

Sponsors and collaborators

Lead sponsor

Action, France

Other

Registry information

Official study title

Online Assistance for Stent Thrombosis

Acronym: ONASSIST

Important dates

Study start
2007
Primary completion
2027
Study completion
2037
First posted
May 4, 2016
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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