Left Atrial Appendage ThrombosisPhase 4NCT04135677
Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO
A Phase 4 study testing Rivaroxaban and DAPT in people with Left Atrial Appendage Thrombosis and Thrombi, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The objective of this study is to assess the efficacy and safety different dosage of rivaroxaban application versus dual antiplatelet therapy after successful closure of left atrial appendage using the LAMBRE device. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Left Atrial Appendage Thrombosis, Thrombi, Stroke
- What is being tested?
- Rivaroxaban and DAPT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2022to 30 Oct 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful transcatheter LAAC using LAMBRE with COST criteria met by intra-procedural TEE and LAA angiography;
- Cha2ds2-Vasc2 score≥2 and or Has-bled score≥3(with contraindication or self-refusal to long-term administration of oral anticoagulants);
- Age18-85 years old;
- Life expectancy≥1 year;
- Written informed consent obtained;
Who cannot join
- • Prior history of cardiac surgery or with need for intervention in limited intervals;
- Intolerant of TEE or with clinical contraindications for TEE
- Detection of LAA/LA thrombus prior to the procedure;
- Anteroposterior diameter of LAA≥60mm according to TTE
- Impairment of renal function: eGFR≤15ml/min and/or creatinine level≥200μmol/L;
- Patients with hepatic disease that is associated with abnormal blood coagulation(cirrhosis: Child Pugh B an C);
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- PLT ≤ 50*10^9/L;
- LVEF≤35% and/or NYHA≥IV；
- Allergies or contraindications to antiplatelet or anticoagulation therapy;
- At high risk of major bleedin(such as gastrointestinal ulcer at present or recently, malignant tumor with high risk of hemorrhage, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, angioaneurysms or major intraspinal or intracerebral vascular malformations, et al)
- Patients with requirement for anticoagulation therapy due to other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.);
- Occurrence of severe pericardial tamponade, major hemorrhage and other life-threatening complications after left atrial appendage closure;
- Combined with other basic complications necessary to take drugs that may affect the effect of anticoagulation and antithrombotic regimen in this study(such as pyrrole antifungal agent, human acquired immunodeficiency virus (HIV) protease inhibitor, anti arrhythmia drug dronedarone, powerful cytochrome enzyme CYP3A4 inducer including rifampicin, phenytoin sodium, carbamazepine, phenobarbital, and other anticoagulants).
- Enrolled in other clinical studies in progress;
- Researches think that the patient is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan Univerisity
Shanghai, Shanghai Municipality, 200032
XIAOCHUN ZHANG, DR
About this study
Official title: A Multi-center Randomized Controlled Study of High/Low-dosage Rivaroxaban Compared With DAPT After Left Atrial Appendage Occulsion in Patients With Non-valvular Atrial Fibrillation（ESCORT-AF Study(B)）
The objective of this study is to assess the efficacy and safety different dosage of rivaroxaban application versus dual antiplatelet therapy after successful closure of left atrial appendage using the LAMBRE device.
Read the detailed description
Transcatheter left atrial appendage occlusion(LAAO) has emerged as an effective alternative for preventing thromboembolic events in patients with nonvalvular atrial fibrillation. The contemporary strategy for post-implantation antithrombotic medication therapy derived from several initial industrialized authoritative researches, demonstrated as 45 days for anticoagulation and prolonged DOAC for 6 months. In spite of the increasing experience of operators and arrival of new technologies, the rates of DRT still maintained. Therefore, whether altered medication therapy post-implantation attracted overwide attention. Nowadays, new oral anticoagulation such as rivaroxaban, dabigatran has evolved empirically and successively has been applied for days-weeks anticoagulation therapy following LAAO ,yet, the specific recommended dosage remained unclear.
Therefore, the objective of the study is to compare the effects of different dosage of rivaroxaban for short-term(12 weeks) anticoagulation therapy versus DAPT for post-LAAO anti-thrombotic therapy.
- Conditions
- Left Atrial Appendage Thrombosis, Thrombi, Stroke
- Being tested
- Rivaroxaban, DAPT
- Medical subject headings
- Thrombosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called new oral anticoagulation
Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards)
DAPTDrug
Also called dual antiplatelet therapy
Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks
| Study group | Role | What they receive |
|---|---|---|
| DAPT group | Active comparator | asprin 100mg qd together clopidogrel 75mg for 24 weeks Receives: Drug: DAPT |
| Anticoagulation group | Experimental | rivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primacy efficacy endpoint
Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)
Measured: 24 weeks after LAAC
Primacy safety endpoint
Number of participants with bleeding events(major or life-threatening)
Measured: 24 weeks after LAAC
Secondary outcomes (6)
Device-related thrombosis
Number and rates of participants with DRT on TEE
Measured: at 12-,24-week follow-up
Stroke
Rates and distribution of participants withischemic and hemorrhagic stroke
Measured: at 12,24-week follow-up
Bleeding
Number and rates of participants with bleeding events in varying severity
Measured: at 12-,24-week follow-up
Death
Number and rates of cardiovascular-related/not cardiovascular-related death
Measured: at 12-,24-week follow-up
Re-hospitalization
Number and rates of participants indicated for re-hospitalization due to cardiovascular diseases
Measured: at 12-,24-week follow-up
Composed endpoint
Number and rates of composed endpoints(DRT, rehospitalization for cardiovascular diseases and other primary endpoints)
Measured: at 12-,24-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start11 Nov 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage ThrombosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 826 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JUNBO GE, PHD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135677
- Sponsor's protocol ID
- DRXCZ
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Study of High/Low-dosage Rivaroxaban Compared With DAPT After Left Atrial Appendage Occulsion in Patients With Non-valvular Atrial Fibrillation（ESCORT-AF Study(B)）
- ClinicalTrials.gov ID
- NCT04135677
- Acronym / sponsor ID
- DRXCZ
- Conditions
- Left Atrial Appendage Thrombosis, Thrombi, Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 826 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Oct 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 objective of this study is to assess the efficacy and safety different dosage of rivaroxaban application versus dual antiplatelet therapy after successful closure of left atrial appendage using the LAMBRE device.
Detailed description
Transcatheter left atrial appendage occlusion(LAAO) has emerged as an effective alternative for preventing thromboembolic events in patients with nonvalvular atrial fibrillation. The contemporary strategy for post-implantation antithrombotic medication therapy derived from several initial industrialized authoritative researches, demonstrated as 45 days for anticoagulation and prolonged DOAC for 6 months. In spite of the increasing experience of operators and arrival of new technologies, the rates of DRT still maintained. Therefore, whether altered medication therapy post-implantation attracted overwide attention. Nowadays, new oral anticoagulation such as rivaroxaban, dabigatran has evolved empirically and successively has been applied for days-weeks anticoagulation therapy following LAAO ,yet, the specific recommended dosage remained unclear.
Therefore, the objective of the study is to compare the effects of different dosage of rivaroxaban for short-term(12 weeks) anticoagulation therapy versus DAPT for post-LAAO anti-thrombotic therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPT group | Active comparator | Drug: DAPTasprin 100mg qd together clopidogrel 75mg for 24 weeks |
| Anticoagulation group | Experimental | Drug: Rivaroxabanrivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successful transcatheter LAAC using LAMBRE with COST criteria met by intra-procedural TEE and LAA angiography;
- Cha2ds2-Vasc2 score≥2 and or Has-bled score≥3(with contraindication or self-refusal to long-term administration of oral anticoagulants);
- Age18-85 years old;
- Life expectancy≥1 year;
- Written informed consent obtained;
Key exclusion criteria (15 listed)
- • Prior history of cardiac surgery or with need for intervention in limited intervals;
- Intolerant of TEE or with clinical contraindications for TEE
- Detection of LAA/LA thrombus prior to the procedure;
- Anteroposterior diameter of LAA≥60mm according to TTE
- Impairment of renal function: eGFR≤15ml/min and/or creatinine level≥200μmol/L;
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 |
|---|---|---|
| RivaroxabanAlso: new oral anticoagulationDrug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards) | Drug | Anticoagulation group |
| DAPTAlso: dual antiplatelet therapyDrug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks | Drug | DAPT group |
Primary outcome
Primacy efficacy endpoint
Time frame: 24 weeks after LAAC
Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)
Primacy safety endpoint
Time frame: 24 weeks after LAAC
Number of participants with bleeding events(major or life-threatening)
6 secondary outcomes
Device-related thrombosis
Time frame: at 12-,24-week follow-up
Stroke
Time frame: at 12,24-week follow-up
Bleeding
Time frame: at 12-,24-week follow-up
Death
Time frame: at 12-,24-week follow-up
Re-hospitalization
Time frame: at 12-,24-week follow-up
Composed endpoint
Time frame: at 12-,24-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
JUNBO GE, PHD study chair
Fudan 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 Rivaroxaban and DAPT in people with Left Atrial Appendage Thrombosis and Thrombi, run by Shanghai Zhongshan 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 5 inclusion and 15 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 15 Nov 2022. 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?
Contact XIAOCHUN ZHANG, DR (15002121366, 514864787@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primacy efficacy endpoint (time frame: 24 weeks after LAAC). 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?
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 15 Nov 2022.