Registry of Coronary Artery Ill Patients With Platelet Test Results

Myocardial Infarction Clinical Trial

— ONASSIST  

Official title:

Online Assistance for Stent Thrombosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762162
• Other study ID #: ONASSIST
• Status: Recruiting
• Start date: January 2007
• Est. completion date: January 2037

Study information

• Verified date: January 2019
• Source: Action, France
• Contact: Jean Philippe COLLET, MD, PhD
• Phone: +33142162962
• Email: jean-philippe.collet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2037
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention

Locations

Country	Name	City	State
France	Hopital Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Action, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding	all bleeding according to the BARC (Bleeding Academic Research Consortium) definitions are registered during the follow up	10 years
Primary	Myocardial Infarction		10 years
Primary	Death		10 years
Primary	Stroke		10 years
Primary	Urgent Revascularization		10 years
Primary	Resuscitated Cardiac Arrest		10 years