Platelet Function in Patients With an Acute Coronary Syndrome (ATLANTIS-ACS)

November 19, 2013 updated by: Jolanta Siller-Matula, Medical University of Vienna

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Recruiting
        • Medical Univerity of Vienna, Department of Cardiology
        • Principal Investigator:
          • Jolanta M Siller-Matula, PD MD PhD
        • Principal Investigator:
          • Georg Delle-Karth, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting with an acute coronary syndrome

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net clinical benefit.
Time Frame: 1 year
A composite of MACE and BARC=>2 bleedings.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE and Major bleeding
Time Frame: 1 year

MACE: the composite of stent thrombosis, cardiac death and myocardial infarction.

Major Bleeding: BARC =>2, TIMI major, GUSTO moderate-severe-life threatening.
1 year

Other Outcome Measures

Outcome Measure
Time Frame
single endpoints of acute coronary syndrome, myocardial infarction, cardiac death, all-cause death, urgent vessel revascularization (PCI or CABG), stroke.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATLANTIS-ACS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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