Atrial FibrillationDIRECTNCT03280641
D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy
An observational study of Atrial Fibrillation and Strokes Thrombotic, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial summary
This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Strokes Thrombotic
- What is being tested?
- Dabigatran Etexilate 110mg and Warfarin Sodium
- How many people
- 1,194 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2015to 1 Sep 2017
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with Non-valvular atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
Who may be able to join
- Non-valvular atrial fibrillation
- Receiving oral anticoagulation therapy and have good compliance
Who cannot join
- Life expectancy less than 1 year
- Thrombosis or major bleeding history within 3 months
- Refusal to Participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy
This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
Read the detailed description
Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was analyzed before and 3 months after anticoagulation starting specificly. Patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.
- Conditions
- Atrial Fibrillation, Strokes Thrombotic
- Being tested
- Dabigatran Etexilate 110mg, Warfarin Sodium
- Medical subject headings
- Atrial Fibrillation, Thrombotic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran Etexilate 110mgDrug
Also called Pradaxa
Dabigatran Etexilate 110mg, BID
Warfarin SodiumDrug
Target INR:1.6-3.0
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran Group | Patiets with atrial fibrillation received dabigatran (110mg, bid). Receives: Drug: Dabigatran Etexilate 110mg | |
| Warfarin Group | Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0 Receives: Drug: Warfarin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Thrombotic events, cardiovascular deaths, major bleeding events
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 posted12 Sep 2017
- Study start9 Aug 2015
- Primary completion30 Jul 2017
- Study completion1 Sep 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Litao ZHANG, MD, Principal investigator, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280641
- Sponsor's protocol ID
- 2015-P-016
- Acronym
- DIRECT
- Status last verified
- Sep 2017
- First submitted
- 10 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share the IPD after the paper being published
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy
- ClinicalTrials.gov ID
- NCT03280641
- Acronym / sponsor ID
- DIRECT / 2015-P-016
- Conditions
- Atrial Fibrillation, Strokes Thrombotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,194 participants (actual)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 9 Aug 2015 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Sep 2017 (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 is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
Detailed description
Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was analyzed before and 3 months after anticoagulation starting specificly. Patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran Group | – | Drug: Dabigatran Etexilate 110mgPatiets with atrial fibrillation received dabigatran (110mg, bid). |
| Warfarin Group | – | Drug: Warfarin SodiumPatiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Non-valvular atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.
Key inclusion criteria (2 listed)
- Non-valvular atrial fibrillation
- Receiving oral anticoagulation therapy and have good compliance
Key exclusion criteria (3 listed)
- Life expectancy less than 1 year
- Thrombosis or major bleeding history within 3 months
- Refusal to Participate
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 |
|---|---|---|
| Dabigatran Etexilate 110mgAlso: PradaxaDabigatran Etexilate 110mg, BID | Drug | Dabigatran Group |
| Warfarin SodiumTarget INR:1.6-3.0 | Drug | Warfarin Group |
Primary outcome
Cardiovascular events
Time frame: 12 months
Thrombotic events, cardiovascular deaths, major bleeding events
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 12 Sep 2017.
- Individual participant dataSharing planned: Undecided. We will share the IPD after the paper being published
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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.
Litao ZHANG, MD principal investigator
Wuhan Asia Heart Hospital
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 Atrial Fibrillation and Strokes Thrombotic, run by Wuhan Asia Heart Hospital 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 2 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 12 Sep 2017. 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.
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?
Cardiovascular events (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 12 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.