Atrial FibrillationPhase 4NCT05671276
Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion
A Phase 4 study testing aspirin and clopidogrel and Rivaroxaban in people with Atrial Fibrillation and Left Atrial Appendage Occlusion, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Occlusion, Silent Cerebral Embolism
- What is being tested?
- aspirin and clopidogrel and Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AF patients over 18 years old
- Patients had undergone left atrial appendage occlusion with WATCHMAN device and confirmed no significant peri-device leak or DRT at the 45-day CT
- Patients have a history of ischemic thromboembolic events or have CHA2DS2-VASc score ≥3
Who cannot join
- Patients with an indication of long-term antiplatelet therapy other than LAAO at the time of enrollment (eg, ACS, Intracranial vascular stenosis≥75%)
- Absolute contraindications to OAC
- Absolute contraindications to anti-platelet therapy
- Contraindications to MR or unwilling to receiving MR
- Patients with clinical thromboembolicor major bleeding events within 45 days after LAA occlusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Kexin Wang, 18018223427, 840507356@qq.com
Weizhu Ju, 15358162522, juweizhu@126.com
About this study
Official title: Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial
The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
Read the detailed description
BACKGROUND Left atrial appendage intervention is increasingly recognized as an alternative strategy for thromboembolism prophylaxis in AF. Theoretically, a complete occlusion of left atrial appendage may eliminate the possibility of embolism from the appendage. However, residual risk exists due to blood stasis and endothelial dysfunction in the atrial fibrillation state. This may raise an issue that whether we should and how to give the patients after appendage occlusion long-term antithrombotic therapy.
Meanwhile, patients with AF have a high incidence of silent cerebral embolism (SCE), which has similar impact with clinical stroke on cognition function. We hypothesized that the SCE caused by micro embolism may act as part of the residual risk after appendage occlusion, thus, an optimal antithrombotic treatment to decrease the incidence of SCE remains unclear.
AIM OF THIS STUDY The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of SCE. The primary endpoint is incidence of SCE detected by MRI. The secondary endpoints are more than two new SCE detected by MRI, cognition function and composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events.
DESIGN This is a randomized, prospective, multicenter design. We aim to include 150 patients 45 days after successful LAAC with WATCHMAN device. Patients are randomized in a 1:1 fashion into two arms: Standard Antiplatelet Therapy and Half-Dose NOAC. Follow-up duration of this study is 12 months. The 1-year routine follow-up strategy included DW-MRI scans performed approximately 90 days, 180 days, and 365 days post-procedure.
- Being tested
- aspirin and clopidogrel, Rivaroxaban
- Keywords
- Atrial Fibrillation, Left Atrial Appendage Occlusion, Silent Cerebral Embolism, Oral Anticoagulation, Antiplatelet Therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin and clopidogrelDrug
DAPT (until 6 months) + ASA
RivaroxabanDrug
half-dose NOAC
| Study group | Role | What they receive |
|---|---|---|
| Standard Antiplatelet Therapy | Active comparator | DAPT (aspirin 100 mg and clopidogrel 75 mg) from 45 days to 6 month-follow-up, then aspirin alone Receives: Drug: aspirin and clopidogrel |
| Half-Dose NOAC | Experimental | Long-term half-dose NOAC (rivaroxaban 10 mg after 45 days) Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of silent cerebral embolism (SCE) detected by MRI
New SCE at any MRI during the follow-up
Measured: 45 days to 12 months
Secondary outcomes (4)
More than two new SCE detected by MRI
More than two new SCE at any MRI during the follow-up, describing the number, location and the size.
Measured: 45 days to 12 months
Cognition function detected by MMSE test
Cognition score detected by MMSE test
Measured: 45 days to 12 months
MoCA test
Cognition score detected by MoCA test
Measured: 45 days to 12 months
Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events
Clinical thromboembolic including Ischemic stroke, Peripheral thromboembolic event, et al. Major bleeding including intracrania bleeding, gastrointestina bleeding et al.
Measured: 45 days to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Feb 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Nantong University, Jiangsu Taizhou People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671276
- Sponsor's protocol ID
- 2022-SR-228
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang K, Shi L, Ruan Z, Jin C, Li M, Liu H, Chen H, Ju W, Chen M. Half-Dose Anticoagulation versus Antiplatelet Therapy to Reduce Silent Cerebral Embolism after Left Atrial Appendage Occlusion (HALO-SCE Study): Rationale and Design of a Randomized Clinical Trial. Cerebrovasc Dis. 2026;55(3):394-399. doi: 10.1159/000547304. Epub 2025 Jul 15.
PubMed 40664179
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05671276
- Acronym / sponsor ID
- 2022-SR-228
- Keywords
- Atrial Fibrillation, Left Atrial Appendage Occlusion, Silent Cerebral Embolism, Oral Anticoagulation, Antiplatelet Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Nantong University, Jiangsu Taizhou People's Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 4 Jan 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 primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
Detailed description
BACKGROUND Left atrial appendage intervention is increasingly recognized as an alternative strategy for thromboembolism prophylaxis in AF. Theoretically, a complete occlusion of left atrial appendage may eliminate the possibility of embolism from the appendage. However, residual risk exists due to blood stasis and endothelial dysfunction in the atrial fibrillation state. This may raise an issue that whether we should and how to give the patients after appendage occlusion long-term antithrombotic therapy.
Meanwhile, patients with AF have a high incidence of silent cerebral embolism (SCE), which has similar impact with clinical stroke on cognition function. We hypothesized that the SCE caused by micro embolism may act as part of the residual risk after appendage occlusion, thus, an optimal antithrombotic treatment to decrease the incidence of SCE remains unclear.
AIM OF THIS STUDY The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of SCE. The primary endpoint is incidence of SCE detected by MRI. The secondary endpoints are more than two new SCE detected by MRI, cognition function and composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events.
DESIGN This is a randomized, prospective, multicenter design. We aim to include 150 patients 45 days after successful LAAC with WATCHMAN device. Patients are randomized in a 1:1 fashion into two arms: Standard Antiplatelet Therapy and Half-Dose NOAC. Follow-up duration of this study is 12 months. The 1-year routine follow-up strategy included DW-MRI scans performed approximately 90 days, 180 days, and 365 days post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Antiplatelet Therapy | Active comparator | Drug: aspirin and clopidogrelDAPT (aspirin 100 mg and clopidogrel 75 mg) from 45 days to 6 month-follow-up, then aspirin alone |
| Half-Dose NOAC | Experimental | Drug: RivaroxabanLong-term half-dose NOAC (rivaroxaban 10 mg after 45 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AF patients over 18 years old
- Patients had undergone left atrial appendage occlusion with WATCHMAN device and confirmed no significant peri-device leak or DRT at the 45-day CT
- Patients have a history of ischemic thromboembolic events or have CHA2DS2-VASc score ≥3
Key exclusion criteria (5 listed)
- Patients with an indication of long-term antiplatelet therapy other than LAAO at the time of enrollment (eg, ACS, Intracranial vascular stenosis≥75%)
- Absolute contraindications to OAC
- Absolute contraindications to anti-platelet therapy
- Contraindications to MR or unwilling to receiving MR
- Patients with clinical thromboembolicor major bleeding events within 45 days after LAA occlusion
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 |
|---|---|---|
| aspirin and clopidogrelDAPT (until 6 months) + ASA | Drug | Standard Antiplatelet Therapy |
| Rivaroxabanhalf-dose NOAC | Drug | Half-Dose NOAC |
Primary outcome
Incidence of silent cerebral embolism (SCE) detected by MRI
Time frame: 45 days to 12 months
New SCE at any MRI during the follow-up
4 secondary outcomes
More than two new SCE detected by MRI
Time frame: 45 days to 12 months
Cognition function detected by MMSE test
Time frame: 45 days to 12 months
MoCA test
Time frame: 45 days to 12 months
Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events
Time frame: 45 days to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 40664179Wang K, Shi L, Ruan Z, Jin C, Li M, Liu H, Chen H, Ju W, Chen M. Half-Dose Anticoagulation versus Antiplatelet Therapy to Reduce Silent Cerebral Embolism after Left Atrial Appendage Occlusion (HALO-SCE Study): Rationale and Design of a Randomized Clinical Trial. Cerebrovasc Dis. 2026;55(3):394-399. doi: 10.1159/000547304. Epub 2025 Jul 15.
- Individual participant dataSharing planned: Undecided
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Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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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.
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 aspirin and clopidogrel and Rivaroxaban in people with Atrial Fibrillation and Left Atrial Appendage Occlusion, 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 5 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 4 Jan 2023. 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 Kexin Wang, MD (18018223427, 840507356@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of silent cerebral embolism (SCE) detected by MRI (time frame: 45 days to 12 months). 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 NCT05671276, 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 4 Jan 2023.