Atrial FibrillationNCT02583971
Assessment of Thrombotic Status in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by East and North Hertfordshire NHS Trust.
Trial summary
Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of interest are adults (>18) diagnosed with atrial fibrillation (AF) who will be treated in one of 3 ways: 1. Medical management 2. Direct current cardioversion 3. AF ablation In total we aim to sample 500 patients divided into: 100 - Medical management 100 - Direct current cardioversion 300 - AF ablation
Who may be able to join
- Male and female patients aged 18 years or over
- Patients diagnosed with atrial fibrillation managed in one of the 3 ways outlined above
- The patient is willing and able to understand the Patient Information Sheet and provide informed consent
- The patient must agree to comply with the drawing of blood samples for the assessments
Who cannot join
- Male and female patients aged < 18 years of age
- The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
- The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease
- Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity
- Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
- Any major bleeding diathesis or blood dyscrasia (platelets < 70 x 109/l, Hb < 8 g/dl, INR > 1.4, APTT > x 2 UNL, leucocyte count < 3.5 x 109/l, neutrophil count < 1 x 109/l)
- Currently enrolled in an investigational device or drug trial
Trial locations and contacts
No sites are listed yet.
Gareth Rosser, MBBS MRCP contact
About this study
Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status
Read the detailed description
AF affects 1 in 4 people in their lifetime. Although generally thought of as a safe heart rhythm disturbance, the risk associated with AF is through the formation of clot (thrombus) within the heart which be ejected from the heart when it contracts causing a heart attack or perhaps more devastatingly a stroke.
The mainstay of treatment for AF involves thinning the blood with drugs such as warfarin or newer drugs termed novel oral anticoagulants. In addition to this there are 3 main ways of treating the underlying rhythm disturbance:
- Accept the irregular heart rhythm and simply control the heart rate with heart rate limiting drugs such as beta blockers or digoxin in addition to the blood thinning medicines.
- Restore the normal heart rhythm with with an electrical shock termed a direct current cardioversion (DCCV). This is usually a temporary measure, indeed 70% of whom will have reverted to AF by 12 months.
- Attempt to permanently restore sinus rhythm through an atrial fibrillation ablation procedure.
The investigators study, through use of a relatively novel bedside test will examine the effects of each of these management strategies on the thrombotic status of the participant's blood.
Investigators will take blood from in total 500 participants divided between each of the above management strategies which has been decided by their parent teams (i.e. study does not affect their treatment).
Investigators will draw blood from the participants on up to 5 separate occasions over a 12 month period. In the group undergoing a DCCV, blood will be drawn shortly before and after the intervention and at 3 and 12 months post intervention. In the group undergoing an AF ablation blood will be drawn on 5 occasions - the day before the procedure, 1-2 days post, 3-4 days post, 3-4 months post and 12 months post. In the group treated with standard medical therapy, blood will be drawn at the time of enrolment in the study and at 3 and 12 months post enrolment.
It is the investigators hypothesis that permanent restoration of sinus rhythm through an atrial fibrillation ablation procedure will positively affect an individual participant's thrombotic status. There has been recent publication of registry data from the United States suggesting the long term rate of stroke in the population following an AF ablation approaches that of the population who have never suffered AF.
The investigators believe that the cause of the improvement in stroke rates following ablation is an improvement in thrombotic status which we hope to be test for the first time in a powered, prospective study.
- Conditions
- Atrial Fibrillation
- Keywords
- Direct current cardioversion, Medical management, Atrial fibrillation ablation
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| Patients with AF | Split into 3: Those patients on treatment for AF involving blood thinning medicines (anticoagulants) +/- heart rate limiting drugs such as B blockers or digoxin. 100 patients in this group. Patients undergoing direct current cardioversion (DCCV) to temporarily restore normal (sinus) rhythm. 100 patients in this group. Patients undergoing an AF ablation to permanently restore sinus rhythm. 300 patients in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic status
This will be assessed using the investigator's novel bedside blood test. Each participant will have blood taken at predetermined points in time over a 12 month period. Some will have blood sampled on 3 different occasions, some on 4 occasions and the majority will have blood sampled on 5 occasions over the 12 months. The Global Thrombosis test provides information of the time taken for whole blood to clot (occlusion time) and then for the clot to naturally break down (lysis time)
Measured: 12 months
Secondary outcomes (1)
Major adverse clinical event (MACE)
Over the time period that investigators are sampling, investigators will also note any major adverse clinical events such as heart attack, stroke or death.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startNov 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Principal investigator, Prof Diana Gorog, East and North Hertfordshire NHS Trust
- Investigators
- Diana Gorog, MD PhD FRCP, Principal investigator, East and North Herts NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583971
- Sponsor's protocol ID
- No. 1.2 Oct 2015
- Status last verified
- Aug 2016
- First submitted
- 21 Oct 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thrombotic Status in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02583971
- Acronym / sponsor ID
- No. 1.2 Oct 2015
- Conditions
- Atrial Fibrillation
- Keywords
- Direct current cardioversion, Medical management, Atrial fibrillation ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Nov 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 22 Oct 2015 (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.
Investigators will assess the impact of treatments for atrial fibrillation on participant's thrombotic status
Detailed description
AF affects 1 in 4 people in their lifetime. Although generally thought of as a safe heart rhythm disturbance, the risk associated with AF is through the formation of clot (thrombus) within the heart which be ejected from the heart when it contracts causing a heart attack or perhaps more devastatingly a stroke.
The mainstay of treatment for AF involves thinning the blood with drugs such as warfarin or newer drugs termed novel oral anticoagulants. In addition to this there are 3 main ways of treating the underlying rhythm disturbance:
- Accept the irregular heart rhythm and simply control the heart rate with heart rate limiting drugs such as beta blockers or digoxin in addition to the blood thinning medicines.
- Restore the normal heart rhythm with with an electrical shock termed a direct current cardioversion (DCCV). This is usually a temporary measure, indeed 70% of whom will have reverted to AF by 12 months.
- Attempt to permanently restore sinus rhythm through an atrial fibrillation ablation procedure.
The investigators study, through use of a relatively novel bedside test will examine the effects of each of these management strategies on the thrombotic status of the participant's blood.
Investigators will take blood from in total 500 participants divided between each of the above management strategies which has been decided by their parent teams (i.e. study does not affect their treatment).
Investigators will draw blood from the participants on up to 5 separate occasions over a 12 month period. In the group undergoing a DCCV, blood will be drawn shortly before and after the intervention and at 3 and 12 months post intervention. In the group undergoing an AF ablation blood will be drawn on 5 occasions - the day before the procedure, 1-2 days post, 3-4 days post, 3-4 months post and 12 months post. In the group treated with standard medical therapy, blood will be drawn at the time of enrolment in the study and at 3 and 12 months post enrolment.
It is the investigators hypothesis that permanent restoration of sinus rhythm through an atrial fibrillation ablation procedure will positively affect an individual participant's thrombotic status. There has been recent publication of registry data from the United States suggesting the long term rate of stroke in the population following an AF ablation approaches that of the population who have never suffered AF.
The investigators believe that the cause of the improvement in stroke rates following ablation is an improvement in thrombotic status which we hope to be test for the first time in a powered, prospective study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with AF | – | –Split into 3: Those patients on treatment for AF involving blood thinning medicines (anticoagulants) +/- heart rate limiting drugs such as B blockers or digoxin. 100 patients in this group. Patients undergoing direct current cardioversion (DCCV) to temporarily restore normal (sinus) rhythm. 100 patients in this group. Patients undergoing an AF ablation to permanently restore sinus rhythm. 300 patients in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of interest are adults (>18) diagnosed with atrial fibrillation (AF) who will be treated in one of 3 ways: 1. Medical management 2. Direct current cardioversion 3. AF ablation In total we aim to sample 500 patients divided into: 100 - Medical management 100 - Direct current cardioversion 300 - AF ablation
Key inclusion criteria (4 listed)
- Male and female patients aged 18 years or over
- Patients diagnosed with atrial fibrillation managed in one of the 3 ways outlined above
- The patient is willing and able to understand the Patient Information Sheet and provide informed consent
- The patient must agree to comply with the drawing of blood samples for the assessments
Key exclusion criteria (7 listed)
- Male and female patients aged < 18 years of age
- The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
- The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease
- Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity
- Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
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
Thrombotic status
Time frame: 12 months
This will be assessed using the investigator's novel bedside blood test. Each participant will have blood taken at predetermined points in time over a 12 month period. Some will have blood sampled on 3 different occasions, some on 4 occasions and the majority will have blood sampled on 5 occasions over the 12 months. The Global Thrombosis test provides information of the time taken for whole blood to clot (occlusion time) and then for the clot to naturally break down (lysis time)
1 secondary outcome
Major adverse clinical event (MACE)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
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Atrial Fibrillation (AF)
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.
Gareth Rosser, MBBS MRCP contact
Diana Gorog, MD PhD FRCP principal investigator
East and North Herts NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by East and North Hertfordshire NHS Trust.
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 7 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 3 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Gorog, MD PhD FRCP (01707247512, mary.odonnell@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic status (time frame: 12 months). 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 3 Aug 2016.