NCT01992484

Brief 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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

November 19, 2013

Last Update Submit

November 19, 2013

Conditions

Acute Coronary Syndrome (ACS)

Keywords

platelets, Acute coronary Syndrome (ACS), prasugrel, ticagrelor, aspirin

Outcome Measures

Primary Outcomes (1)

  • Net clinical benefit.

    A composite of MACE and BARC=\>2 bleedings.

    1 year

Secondary Outcomes (1)

  • MACE and Major bleeding

    1 year

Other Outcomes (1)

  • single endpoints of acute coronary syndrome, myocardial infarction, cardiac death, all-cause death, urgent vessel revascularization (PCI or CABG), stroke.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting with an acute coronary syndrome

You may qualify if:

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

You may not qualify if:

  • \* Participation in interventional trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Univerity of Vienna, Department of Cardiology

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Jolanta M Siller-Matula, PD MD PhD

CONTACT

0043 1 404004614jolanta.siller-matula@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.med. PhD

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

AU(1)