Acute Coronary SyndromeNCT01623700
Outcome of Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
Trial summary
This observational study will based on the Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for Enhancement and Development of Evidence-based care… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- How many people
- 78,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2006to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients previously enrolled into the SWEDEHEART (RIKS-HIA/SCAAR/SEPHIA) registry from 1 Jan 2006 to 1 July 2010 with an event of ACS and observed during the index hospitalization following enrollment.
Who may be able to join
- Patient with an event of ACS under the study period
- Patient found in the National Registry of Drug Prescriptions and treated or not treated with antithrombotic drug/s (acetylsalicylic acid and/or either clopidogrel/ticlopidine/prasugrel and/or warfarin)
Who cannot join
- Patients will not be excluded from the database if they fulfill inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University
Uppsala, Uppsala County, 75237
About this study
Official title: A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients
This observational study will based on the Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART).
The aim of this study is to investigate the impact of different antithrombotic treatment options (treatment duration, type of treatment and combination of treatments) in Acute Coronary Syndrome (ACS) patients on outcomes such as recurrent ischemic events and mortality.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- clopidogrel, aspirin, percutaneous coronary intervention, coronary stenting, antiplatelet
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dual antiplatelet treatment 12 months after ACS event | Not described | |
| dual antiplatelet treatment 6 months after ACS event | Not described | |
| dual antiplatelet treatment 3 months after ACS event | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adverse events in patient groups with different antithrombotic treatment strategies
adverse events such as: mortality, re-infarction, revascularization, ischemic- and non-ischemic stroke and bleeding
Measured: up to 5 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Retrospective
- Enrolment
- 78,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Stefan James, MD, PhD, Principal investigator, Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623700
- Sponsor's protocol ID
- U-11-001
- Status last verified
- May 2011
- First submitted
- 29 May 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Varenhorst C, Jensevik K, Jernberg T, Sundstrom A, Hasvold P, Held C, Lagerqvist B, James S. Duration of dual antiplatelet treatment with clopidogrel and aspirin in patients with acute coronary syndrome. Eur Heart J. 2014 Apr;35(15):969-78. doi: 10.1093/eurheartj/eht438. Epub 2013 Oct 11.
PubMed 24122961
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT01623700
- Acronym / sponsor ID
- U-11-001
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- clopidogrel, aspirin, percutaneous coronary intervention, coronary stenting, antiplatelet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78,000 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2006
- First posted
- 20 Jun 2012 (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.
This observational study will based on the Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA) and the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) which since 2009 are merged into The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART).
The aim of this study is to investigate the impact of different antithrombotic treatment options (treatment duration, type of treatment and combination of treatments) in Acute Coronary Syndrome (ACS) patients on outcomes such as recurrent ischemic events and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dual antiplatelet treatment 12 months after ACS event | – | – |
| dual antiplatelet treatment 6 months after ACS event | – | – |
| dual antiplatelet treatment 3 months after ACS event | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously enrolled into the SWEDEHEART (RIKS-HIA/SCAAR/SEPHIA) registry from 1 Jan 2006 to 1 July 2010 with an event of ACS and observed during the index hospitalization following enrollment.
Key inclusion criteria (2 listed)
- Patient with an event of ACS under the study period
- Patient found in the National Registry of Drug Prescriptions and treated or not treated with antithrombotic drug/s (acetylsalicylic acid and/or either clopidogrel/ticlopidine/prasugrel and/or warfarin)
Key exclusion criteria (1 listed)
- Patients will not be excluded from the database if they fulfill inclusion criteria.
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
number of patients with adverse events in patient groups with different antithrombotic treatment strategies
Time frame: up to 5 years and 6 months
adverse events such as: mortality, re-infarction, revascularization, ischemic- and non-ischemic stroke and bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 24122961Varenhorst C, Jensevik K, Jernberg T, Sundstrom A, Hasvold P, Held C, Lagerqvist B, James S. Duration of dual antiplatelet treatment with clopidogrel and aspirin in patients with acute coronary syndrome. Eur Heart J. 2014 Apr;35(15):969-78. doi: 10.1093/eurheartj/eht438. Epub 2013 Oct 11.
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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.
Stefan James, MD, PhD principal investigator
Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology
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 and Myocardial Infarction, run by Uppsala University at 1 site in Sweden.
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 2 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 20 Jun 2012. 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with adverse events in patient groups with different antithrombotic treatment strategies (time frame: up to 5 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623700, which also lists 1 linked publication.
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 20 Jun 2012.