Atrial FibrillationNCT06137794
Application of "I-Anticoagulation"in Patients With Atrial Fibrillation
A study testing Use of "I-Anticoagulation" to make the decision and manage patients in people with Atrial Fibrillation and Anticoagulants, run by RenJi Hospital.
Trial summary
The goal of this prospective, multicenter, cluster randomized controlled trial is to assess the effectiveness of a shared decision-making tool, "I-Anticoagulation", for anticoagulation management in AF patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Anticoagulants
- What is being tested?
- Use of "I-Anticoagulation" to make the decision and manage patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 30 Jun 2025
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are 18 years or older and have received a new diagnosis of paroxysmal, persistent, or permanent AF confirmed by electrocardiogram (ECG) or 24-hour Holter monitors
- must be willing to participate in the study and sign the informed consent
Who cannot join
- those who are pregnant
- those whohave experienced therapeutic or subtherapeutic bleeding complications in the last 6 months
- those who have severe renal insufficiency (creatinine clearance rate, CrCl ≤ 20 ml/min)
- those who have severe hepatic insufficiency (Child-Pugh ≥ 10 points)
- those who have severe heart failure (cardiac function New York Heart Association, NYHA grade IV and above)
- those who have severe infection and respiratory failure
- those who are unable to comply with the study requirements.
About this study
Official title: Application of the Anticoagulation Decision-making and Management Model Based on the "I-Anticoagulation" Tool in Patients With Atrial Fibrillation: A Prospective, Multicenter, Cluster Randomized Controlled Study
The goal of this prospective, multicenter, cluster randomized controlled trial is to assess the effectiveness of a shared decision-making tool, "I-Anticoagulation", for anticoagulation management in AF patients. The main questions it aims to answer are:
- whether "I-Anticoagulation" could help improve the rational use of anticoagulants in AF patients;
- whether "I-Anticoagulation" could help increase the adherence and satisfaction of AF patients receiving anticoagulants.
Read more
The anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy.
Researchers will compare the outcomes with the control group, in which patients with AF will receive standard care.
- Conditions
- Atrial Fibrillation, Anticoagulants
- Being tested
- Use of "I-Anticoagulation" to make the decision and manage patients
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of "I-Anticoagulation" to make the decision and manage patientsOther
I-Anticoagulation will offer a flexible and efficient communication platform for healthcare professionals and AF patients. The tool is composed of two modules: an anticoagulation decision support system and a full-process patient management system.
| Study group | Role | What they receive |
|---|---|---|
| SDM group | Experimental | The anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy. Receives: Other: Use of "I-Anticoagulation" to make the decision and manage patients |
| Control group | No intervention | AF patients in the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any bleeding events
Any bleeding events, including both major and minor bleeding events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Minor bleeding events, such as mild nasal hemorrhage, endoscopic haematuria, skin stasis, or mild hemorrhoids, do not lead to serious consequences.
Measured: 1st, 3rd, 6th, 9th, and 12th months
Secondary outcomes (6)
The accordance of stroke prophylaxis for AF according to current guidelines
The accordance of stroke prophylaxis for AF according to current guidelines, i.e., whether the prescriptions meet the recommendations on clinical guidelines, including the choice, usage and dosage of oral anticoagulants.
Measured: 1st, 3rd, 6th, 9th, and 12th months
The percentage of time in the target INR range for patients using warfarin
The percentage of time in which the INR remains in the 1.8 to 3.0 target range across time for patients using warfarin.
Measured: 1st, 3rd, 6th, 9th, and 12th months
The occurrences of major bleeding and thrombosis events
The occurrences of major bleeding and thrombosis events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Thrombosis events, including ischaemic stroke, systemic embolism, and transient ischaemic attacks, will be confirmed by imaging methods such as ultrasound, CT, or MRI.
Measured: 1st, 3rd, 6th, 9th, and 12th months
OAC knowledge of AF patients receiving anticoagulation therapy
The AKT comprises 28 items assessing general anticoagulation knowledge for all available OAC and a specific section for VKAs therapy.
Measured: 1st, 3rd, 6th, 9th, and 12th months
OAC adherence of AF patients receiving anticoagulation therapy
The MARS-5 assesses common patterns of nonadherent behavior.
Measured: 1st, 3rd, 6th, 9th, and 12th months
Satisfaction of AF patients receiving anticoagulation therapy
The ACTS evaluates the burdens and benefits of anticoagulation treatment and its overall impact.
Measured: 1st, 3rd, 6th, 9th, and 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (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.
- More trials run by RenJi HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137794
- Sponsor's protocol ID
- IIT-2023-0207
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Anticoagulation Decision-making and Management Model Based on the "I-Anticoagulation" Tool in Patients With Atrial Fibrillation: A Prospective, Multicenter, Cluster Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06137794
- Acronym / sponsor ID
- IIT-2023-0207
- Conditions
- Atrial Fibrillation, Anticoagulants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
The goal of this prospective, multicenter, cluster randomized controlled trial is to assess the effectiveness of a shared decision-making tool, "I-Anticoagulation", for anticoagulation management in AF patients. The main questions it aims to answer are:
- whether "I-Anticoagulation" could help improve the rational use of anticoagulants in AF patients;
- whether "I-Anticoagulation" could help increase the adherence and satisfaction of AF patients receiving anticoagulants.
The anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy.
Researchers will compare the outcomes with the control group, in which patients with AF will receive standard care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDM group | Experimental | Other: Use of "I-Anticoagulation" to make the decision and manage patientsThe anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy. |
| Control group | No intervention | –AF patients in the control group will receive standard care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are 18 years or older and have received a new diagnosis of paroxysmal, persistent, or permanent AF confirmed by electrocardiogram (ECG) or 24-hour Holter monitors
- must be willing to participate in the study and sign the informed consent
Key exclusion criteria (7 listed)
- those who are pregnant
- those whohave experienced therapeutic or subtherapeutic bleeding complications in the last 6 months
- those who have severe renal insufficiency (creatinine clearance rate, CrCl ≤ 20 ml/min)
- those who have severe hepatic insufficiency (Child-Pugh ≥ 10 points)
- those who have severe heart failure (cardiac function New York Heart Association, NYHA grade IV and above)
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 |
|---|---|---|
| Use of "I-Anticoagulation" to make the decision and manage patientsI-Anticoagulation will offer a flexible and efficient communication platform for healthcare professionals and AF patients. The tool is composed of two modules: an anticoagulation decision support system and a full-process patient management system. | Other | SDM group |
Primary outcome
Any bleeding events
Time frame: 1st, 3rd, 6th, 9th, and 12th months
Any bleeding events, including both major and minor bleeding events. Major bleeding events include fatal haemorrhage, life-threatening bleeding, and severe bleeding requiring treatment or assessment. Severe bleeding can manifest as gastric intestinal haemorrhage, joint haematoma, retroperitoneal haemorrhage, fundus haemorrhage, urine, haemoptysis, or require blood transfusion of at least two units. Minor bleeding events, such as mild nasal hemorrhage, endoscopic haematuria, skin stasis, or mild hemorrhoids, do not lead to serious consequences.
6 secondary outcomes
The accordance of stroke prophylaxis for AF according to current guidelines
Time frame: 1st, 3rd, 6th, 9th, and 12th months
The percentage of time in the target INR range for patients using warfarin
Time frame: 1st, 3rd, 6th, 9th, and 12th months
The occurrences of major bleeding and thrombosis events
Time frame: 1st, 3rd, 6th, 9th, and 12th months
OAC knowledge of AF patients receiving anticoagulation therapy
Time frame: 1st, 3rd, 6th, 9th, and 12th months
OAC adherence of AF patients receiving anticoagulation therapy
Time frame: 1st, 3rd, 6th, 9th, and 12th months
Satisfaction of AF patients receiving anticoagulation therapy
Time frame: 1st, 3rd, 6th, 9th, and 12th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Use of "I-Anticoagulation" to make the decision and manage patients in people with Atrial Fibrillation and Anticoagulants, run by RenJi Hospital.
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 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 18 Nov 2023. 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?
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?
Any bleeding events (time frame: 1st, 3rd, 6th, 9th, and 12th 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 18 Nov 2023.