Acute Coronary Syndrome (ACS)ATLANTIS-ACSNCT01992484
Platelet Function in Patients With an Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome (ACS), run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with an acute coronary syndrome
Who may be able to join
- Signed informed consent
- Acute coronary syndrome at admission
- Planned treatment with novel platelet inhibitors
- Age >18
Who cannot join
- Participation in interventional trials
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical Univerity of Vienna, Department of Cardiology
Vienna
Jolanta M Siller-Matula, PD MD PhD
Georg Delle-Karth, MD
About this study
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
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
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- platelets, Acute coronary Syndrome (ACS), prasugrel, ticagrelor, aspirin
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Net clinical benefit.
A composite of MACE and BARC=>2 bleedings.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Siller-Matula, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992484
- Sponsor's protocol ID
- ATLANTIS-ACS
- Acronym
- ATLANTIS-ACS
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01992484
- Acronym / sponsor ID
- ATLANTIS-ACS / ATLANTIS-ACS
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- platelets, Acute coronary Syndrome (ACS), prasugrel, ticagrelor, aspirin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with an acute coronary syndrome
Key inclusion criteria (4 listed)
- Signed informed consent
- Acute coronary syndrome at admission
- Planned treatment with novel platelet inhibitors
- Age >18
Key exclusion criteria (1 listed)
- Participation in interventional trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Net clinical benefit.
Time frame: 1 year
A composite of MACE and BARC=>2 bleedings.
1 secondary outcome
MACE and Major bleeding
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome (ACS), run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jolanta M Siller-Matula, PD MD PhD (0043 1 404004614, jolanta.siller-matula@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net clinical benefit. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.