Anticoagulants Causing Adverse Effects in Therapeutic UseCarebbean-eNCT03828162
Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly
An observational study of Anticoagulants Causing Adverse Effects in Therapeutic Use and Atrial Fibrillation, run by Karolinska Institutet.
Trial summary
This study was designed to assess the effectiveness of oral anticoagulants in elderly patients (>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Anticoagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Frail Elderly Syndrome
- What is being tested?
- Anticoagulants
- How many people
- 2,943 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2010to 31 Dec 2018
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Prospective cardiovascular cohort
Who may be able to join
- All consecutive patients discharged with atrial fibrillation as main diagnosis from Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.
Who cannot join
- Patients who have not given their consensus to the use of medical journals for register based research.
- Patients who were discharged from the hospital with atrial fibrillation as main diagnosis but were admitted to the hospital for medical reasons unrelated to atrial fibrillation (as an example change of pacemakers batteries).
- Patients whose medical records are not consistent with the main diagnosis (as an example wrong ICD code).
About this study
Official title: Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (>=75 Years)
This study was designed to assess the effectiveness of oral anticoagulants in elderly patients (>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to mandatory and qualitative national registries and review of the medical records until december 31 2018.
Read the detailed description
The investigators established a prospective cohort of 2943 of elderly (>=75 years old) discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st 2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital. Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial fibrillation and atrial flutter) according to the International Classification of Diseases, 10th revision. The first admission to the hospital during the study period is recorded as the index admission.
Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at admission and at discharge have been recorded for each patient through the screening of medical journals.
- Conditions
- Anticoagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Frail Elderly Syndrome
- Being tested
- Anticoagulants
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulantsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke and peripheral embolism
Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.
Measured: 2011-11-01 to 2018-12-31
Bleeding requiring hospitalization
Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029).
Data are extracted from the swedish national patients register.
Measured: 2011-11-01 to 2018-12-31
Cardiovascular death
Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.
Measured: 2011-11-01 to 2018-12-31
Secondary outcomes (1)
Acute coronary syndrome
Acute coronary syndrome have been defined according to the International Classification of Diseases (ICD-10) by the codes: I20-I24.
Data are extracted from the swedish national patients register.
Measured: 2011-11-01 to 2018-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Nov 2010
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 2,943 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruna Gigante, Karolinska Institutet
- Investigators
- Bruna Gigante, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828162
- Sponsor's protocol ID
- OAC and elderly
- Acronym
- Carebbean-e
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Data will be shared according to the rules on privacy at Karolinska Institutet and according to General Data Protection Regulations in Europe. Individual data will not be shared, but summary statistics of the variable of interest will be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (>=75 Years)
- ClinicalTrials.gov ID
- NCT03828162
- Acronym / sponsor ID
- Carebbean-e / OAC and elderly
- Conditions
- Anticoagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,943 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Feb 2019 (actual)
- 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 study was designed to assess the effectiveness of oral anticoagulants in elderly patients (>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to mandatory and qualitative national registries and review of the medical records until december 31 2018.
Detailed description
The investigators established a prospective cohort of 2943 of elderly (>=75 years old) discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st 2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital. Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial fibrillation and atrial flutter) according to the International Classification of Diseases, 10th revision. The first admission to the hospital during the study period is recorded as the index admission.
Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at admission and at discharge have been recorded for each patient through the screening of medical journals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Prospective cardiovascular cohort
Key inclusion criteria (1 listed)
- All consecutive patients discharged with atrial fibrillation as main diagnosis from Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.
Key exclusion criteria (3 listed)
- Patients who have not given their consensus to the use of medical journals for register based research.
- Patients who were discharged from the hospital with atrial fibrillation as main diagnosis but were admitted to the hospital for medical reasons unrelated to atrial fibrillation (as an example change of pacemakers batteries).
- Patients whose medical records are not consistent with the main diagnosis (as an example wrong ICD code).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulants | Drug | – |
Primary outcome
Ischemic stroke and peripheral embolism
Time frame: 2011-11-01 to 2018-12-31
Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.
Bleeding requiring hospitalization
Time frame: 2011-11-01 to 2018-12-31
Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029). Data are extracted from the swedish national patients register.
Cardiovascular death
Time frame: 2011-11-01 to 2018-12-31
Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.
1 secondary outcome
Acute coronary syndrome
Time frame: 2011-11-01 to 2018-12-31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Yes. Data will be shared according to the rules on privacy at Karolinska Institutet and according to General Data Protection Regulations in Europe. Individual data will not be shared, but summary statistics of the variable of interest will be provided upon request.
Related trials for Anticoagulants Causing Adverse Effects in Therapeutic Use
RecruitingObservational study
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
Antiphospholipid Syndrome, Thrombosis
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.
Bruna Gigante, MD PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulants Causing Adverse Effects in Therapeutic Use and Atrial Fibrillation, run by Karolinska Institutet.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ischemic stroke and peripheral embolism (time frame: 2011-11-01 to 2018-12-31). The study lists 3 primary outcomes in all. 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 4 Feb 2019.