Atrial FibrillationNCT03792152
A Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
A study testing Rivaroxaban and Warfarin in people with Atrial Fibrillation and Left Atrial Appendage Thrombosis, run by The Second Affiliated Hospital of Chongqing Medical University.
Trial summary
The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Thrombosis, Rivaroxaban
- What is being tested?
- Rivaroxaban and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 30 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Get informed consent from the patient or family.
- Non-valvular atrial fibrillation / atrial flutter.
- The first transesophageal echocardiogram revealed a left atrial appendage thrombus (within 7 days of detection of thrombus).
- Age at 18-80 years old.
- CrCL≥ 30 mL/min (Cockcroft-Gault).
- AST/ALT is less than 2 times the upper limit of normal.
- Women of childbearing age need contraception.
Who cannot join
- Pregnant or lactating woman.
- Can't understand or follow the research plan.
- Patients under 18 or over 80 years old.
- Low weight (< 40 kg).
- Previously found LAA thrombus and have taken anticoagulant drugs.
- Patients with contraindications for anticoagulation.
Show all 12Show fewer
- Patients who need to use antiplatelet drugs simultaneously within 6-12 months after ACS or PCI.
- A history of cerebral hemorrhage.
- Patients with active bleeding.
- Severe gastritis, gastroesophageal reflux patients.
- Combination of P-glycoprotein inhibitors and other drugs in the presence of NOAC contraindications.
- 13.Patient with tumor. 14.Planned surgery within 3 months. 15.Other investigators believe that patients are not suitable for enrollment.
Trial locations and contacts
No sites are listed yet.
YANPING XU contact
About this study
Official title: A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation.
Read the detailed description
Left atrial appendage (LAA) thrombosis is a common complication of atrial fibrillation and will significantly increase the incidence of stroke in patients. Warfarin is a classical oral anticoagulant which can dissolve thrombus, but its clinical use has many limitations and it requires strict monitoring of coagulation. Recently, some studies have shown that NOAC (dabigatran / rivaroxaban) can dissolve left atrial appendage thrombosis. The application of rivaroxaban in the X-TRA study dissolved 41.5% of LAA thrombus after 6 weeks, indicating its potential clinical application prospects. Whether rivaroxaban is not inferior to warfarin for rapid dissolution of LAA thrombus, there is no prospective randomized controlled trial.
- Being tested
- Rivaroxaban, Warfarin
- Keywords
- Atrial Fibrillation, Left Atrial Appendage Thrombosis, rivaroxaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd (15mg If creatinine clearance is between 30-49 ml/min).
WarfarinDrug
After the diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin (4000iu q12h) and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2.
| Study group | Role | What they receive |
|---|---|---|
| rivaroxaban | Experimental | After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd(15mg If creatinine clearance is between 30-49 ml/min ). Receives: Drug: Rivaroxaban |
| Warfarin | Active comparator | After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks
Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 3rd, 6th week after initiation of anticoagulant therapy.
Measured: 6 weeks
Secondary outcomes (4)
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks
Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy.
Measured: 12 weeks
Size change of left atrial appendage or left atrium thrombus
If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography。
Measured: 12 weeks
Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
Measured: 12 weeks
Number of transient ischemic attacks (TIA) and strokes
Number of transient ischemic attacks (TIA) and strokes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion30 Dec 2022 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, group one is for Rivaroxaban 20mg qd (15mg qd If creatinine clearance is between 30-49ml/min), group two is for warfarin, keep the INR between 2-3.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792152
- Sponsor's protocol ID
- REVIEW-AF
- Status last verified
- Mar 2019
- First submitted
- 31 Dec 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.
PubMed 27502860
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03792152
- Acronym / sponsor ID
- REVIEW-AF
- Keywords
- Atrial Fibrillation, Left Atrial Appendage Thrombosis, rivaroxaban
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 Jan 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.
The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation.
Detailed description
Left atrial appendage (LAA) thrombosis is a common complication of atrial fibrillation and will significantly increase the incidence of stroke in patients. Warfarin is a classical oral anticoagulant which can dissolve thrombus, but its clinical use has many limitations and it requires strict monitoring of coagulation. Recently, some studies have shown that NOAC (dabigatran / rivaroxaban) can dissolve left atrial appendage thrombosis. The application of rivaroxaban in the X-TRA study dissolved 41.5% of LAA thrombus after 6 weeks, indicating its potential clinical application prospects. Whether rivaroxaban is not inferior to warfarin for rapid dissolution of LAA thrombus, there is no prospective randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups, group one is for Rivaroxaban 20mg qd (15mg qd If creatinine clearance is between 30-49ml/min), group two is for warfarin, keep the INR between 2-3.
| Arm | Type | Receives |
|---|---|---|
| rivaroxaban | Experimental | Drug: RivaroxabanAfter diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd(15mg If creatinine clearance is between 30-49 ml/min ). |
| Warfarin | Active comparator | Drug: WarfarinAfter diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Get informed consent from the patient or family.
- Non-valvular atrial fibrillation / atrial flutter.
- The first transesophageal echocardiogram revealed a left atrial appendage thrombus (within 7 days of detection of thrombus).
- Age at 18-80 years old.
- CrCL≥ 30 mL/min (Cockcroft-Gault).
Key exclusion criteria (12 listed)
- Pregnant or lactating woman.
- Can't understand or follow the research plan.
- Patients under 18 or over 80 years old.
- Low weight (< 40 kg).
- Previously found LAA thrombus and have taken anticoagulant drugs.
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 |
|---|---|---|
| RivaroxabanAfter diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd (15mg If creatinine clearance is between 30-49 ml/min). | Drug | rivaroxaban |
| WarfarinAfter the diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin (4000iu q12h) and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2. | Drug | Warfarin |
Primary outcome
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks
Time frame: 6 weeks
Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 3rd, 6th week after initiation of anticoagulant therapy.
4 secondary outcomes
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks
Time frame: 12 weeks
Size change of left atrial appendage or left atrium thrombus
Time frame: 12 weeks
Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.
Time frame: 12 weeks
Number of transient ischemic attacks (TIA) and strokes
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 27502860Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.
- Individual participant dataSharing planned: No
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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.
YANPING XU contact
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban and Warfarin in people with Atrial Fibrillation and Left Atrial Appendage Thrombosis, run by The Second Affiliated Hospital of Chongqing Medical University.
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 7 inclusion and 12 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 19 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZHIYU LING, MD (+8613512362075, lingzy1977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks (time frame: 6 weeks). 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 NCT03792152, 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 19 Mar 2019.