Atrial FibrillationPhase 4NCT02646267
The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients
A Phase 4 study testing standard intensity warfarin, low intensity warfarin and dabigatran etexilate in people with Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- standard intensity warfarin, low intensity warfarin and dabigatran etexilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Aug 2018
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of atrial fibrillation
- Echocardiography confirmed a non-valvular heart disease
- Age≥60 years
Who cannot join
- Unable to cooperate with doctors
- CHA2DS2-VASc<2
- Life expectancy of less than 1 year
- Rheumatic heart disease or dilated cardiomyopathy
- History of artificial valve replacement surgery
- Infectious endocarditis
Show all 13Show fewer
- Stroke or transient ischemic attack(TIA) within the last 6 months
- Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
- Previous intolerance/allergy to warfarin or dabigatran etexilate
- Blood pressure greater than 180/110 mmHg
- Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
- Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
- Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: The Efficacy and Safety of Dabigatran Etexilate and Different Intensity Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation
The purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- standard intensity warfarin, low intensity warfarin, dabigatran etexilate
- Keywords
- Atrial fibrillation, Dabigatran, Warfarin, Anticoagulation, Elderly
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard intensity warfarinDrug
target international normalised ratio(INR) was 2.1-3.0
low intensity warfarinDrug
target international normalised ratio(INR) was 1.7-2.2
dabigatran etexilateDrug
110mg, twice a day, oral
| Study group | Role | What they receive |
|---|---|---|
| standard intensity warfarin group | Experimental | standard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0) Receives: Drug: standard intensity warfarin |
| low intensity warfarin group | Experimental | low intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2) Receives: Drug: low intensity warfarin |
| dabigatran etexilate group | Active comparator | 110mg dabigatran etexilate was administrated twice a day Receives: Drug: dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischaemic stroke
ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting >24 hours.
Measured: 2 years
major haemorrhage
Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units.
Measured: 2 years
Secondary outcomes (5)
minor bleeding
Measured: 2 years
myocardial infarction
Measured: 2 years
pulmonary embolism
Measured: 2 years
cardiovascular death
Measured: 2 years
all-cause mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018 (estimated)
- Study completionAug 2018 (estimated)
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Jun, doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646267
- Sponsor's protocol ID
- SEL102
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 2016
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.
PubMed 23200268
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Dabigatran Etexilate and Different Intensity Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02646267
- Acronym / sponsor ID
- SEL102
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Dabigatran, Warfarin, Anticoagulation, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 5 Jan 2016 (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 purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard intensity warfarin group | Experimental | Drug: standard intensity warfarinstandard intensity warfarin group， target international normalised ratio(INR) was 2.1-3.0, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(2.1-3.0) |
| low intensity warfarin group | Experimental | Drug: low intensity warfarinlow intensity warfarin group， target international normalised ratio(INR) was 1.7-2.2, warfarin baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range(1.7-2.2) |
| dabigatran etexilate group | Active comparator | Drug: dabigatran etexilate110mg dabigatran etexilate was administrated twice a day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of atrial fibrillation
- Echocardiography confirmed a non-valvular heart disease
- Age≥60 years
Key exclusion criteria (13 listed)
- Unable to cooperate with doctors
- CHA2DS2-VASc<2
- Life expectancy of less than 1 year
- Rheumatic heart disease or dilated cardiomyopathy
- History of artificial valve replacement surgery
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 |
|---|---|---|
| standard intensity warfarintarget international normalised ratio(INR) was 2.1-3.0 | Drug | standard intensity warfarin group |
| low intensity warfarintarget international normalised ratio(INR) was 1.7-2.2 | Drug | low intensity warfarin group |
| dabigatran etexilate110mg, twice a day, oral | Drug | dabigatran etexilate group |
Primary outcome
ischaemic stroke
Time frame: 2 years
ischaemic stroke was defined as a blockage in an artery that supplies blood to the brain , resulting in a deficiency in blood flow and focal neurological deficit lasting >24 hours.
major haemorrhage
Time frame: 2 years
Major haemorrhage was defined as intracranial hemorrhage, gastrointestinal bleeding, bleeding requiring hospitalization and surgical intervention, a reduction of hemoglobin by≥2 g/dL, requiring red blood cells transfusion ≥2 units.
5 secondary outcomes
minor bleeding
Time frame: 2 years
myocardial infarction
Time frame: 2 years
pulmonary embolism
Time frame: 2 years
cardiovascular death
Time frame: 2 years
all-cause mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 23200268Wu J, Wang J, Jiang S, Xu J, Di Q, Zhou C, Min X, Pang S, Wang H, Xu D, Guo Y. The efficacy and safety of low intensity warfarin therapy in Chinese elderly atrial fibrillation patients with high CHADS2 risk score. Int J Cardiol. 2013 Sep 10;167(6):3067-8. doi: 10.1016/j.ijcard.2012.11.078. Epub 2012 Nov 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
Wu Jun, doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standard intensity warfarin, low intensity warfarin and dabigatran etexilate in people with Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 3 inclusion and 13 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 5 Jan 2016. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ischaemic stroke (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02646267, 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 5 Jan 2016.