Platelet Function in Patients With an Acute Coronary Syndrome

Acute Coronary Syndrome (ACS) Clinical Trial

— ATLANTIS-ACS  

Official title:

Association Between the Antiplatelet Drug Efficacy/Safety and Platelet Function in Patients Treated With Novel Platelet Inhibitors Due to an Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992484
• Other study ID #: ATLANTIS-ACS
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 19, 2013
• Start date: August 2012

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: Jolanta M Siller-Matula, PD MD PhD
• Phone: 0043 1 404004614
• Email: jolanta.siller-matula[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The aims of the study are to:

• explore whether platelet reactivity in patients treated wih novel platelet inhibitors is associated with clinical outcome

• investigate whether a therapeutic window exist for novel platelet inhibitors

• investigate the incidence of adverse events under treatment with novel platelet inhibitors in the real life clinical scenario

• investigate the association between genetic polymorphisms, inflammation, platelet reactivity and clinical outcome

• investigate synergistic effects between aspirin and novel platelet inhibitors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Acute coronary syndrome at admission

• Planned treatment with novel platelet inhibitors

• Age >18

Exclusion Criteria:

• Participation in interventional trials

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Syndrome

Locations

Country	Name	City	State
Austria	Medical Univerity of Vienna, Department of Cardiology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	single endpoints of acute coronary syndrome, myocardial infarction, cardiac death, all-cause death, urgent vessel revascularization (PCI or CABG), stroke.		1 year	No
Primary	Net clinical benefit.	A composite of MACE and BARC=>2 bleedings.	1 year	Yes
Secondary	MACE and Major bleeding	MACE: the composite of stent thrombosis, cardiac death and myocardial infarction.; Major Bleeding: BARC =>2, TIMI major, GUSTO moderate-severe-life threatening.	1 year	Yes