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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Jolanta Siller-Matula, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01992484
First received: November 19, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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

Condition
Acute Coronary Syndrome (ACS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Net clinical benefit. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    A composite of MACE and BARC=>2 bleedings.


Secondary Outcome Measures:
  • MACE and Major bleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

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



Other Outcome Measures:
  • single endpoints of acute coronary syndrome, myocardial infarction, cardiac death, all-cause death, urgent vessel revascularization (PCI or CABG), stroke. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting with an acute coronary syndrome

Criteria

Inclusion Criteria:

  • Signed informed consent
  • Acute coronary syndrome at admission
  • Planned treatment with novel platelet inhibitors
  • Age >18

Exclusion Criteria:

* Participation in interventional trials

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992484

Contacts
Contact: Jolanta M Siller-Matula, PD MD PhD 0043 1 404004614 jolanta.siller-matula@meduniwien.ac.at

Locations
Austria
Medical Univerity of Vienna, Department of Cardiology Recruiting
Vienna, Austria
Principal Investigator: Jolanta M Siller-Matula, PD MD PhD         
Principal Investigator: Georg Delle-Karth, MD         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Jolanta Siller-Matula, PD Dr.med. PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01992484     History of Changes
Other Study ID Numbers: ATLANTIS-ACS
Study First Received: November 19, 2013
Last Updated: November 19, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
platelets, Acute coronary Syndrome (ACS), prasugrel, ticagrelor, aspirin

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014