Atrial FibrillationRECORD-IIINCT05960721
Low-dose NOAC Versus GDMT After LAAO
A study testing Rivaroxaban 15mg, Aspirin 100mg and Clopidogrel 75mg in people with Atrial Fibrillation, run by Xijing Hospital at 1 site in China.
Trial summary
The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban 15mg, Aspirin 100mg and Clopidogrel 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,220 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2023to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Non-valvular atrial fibrillation (NVAF) patients with successful left atrial appendage occlusion (LAAO)
- Eligible for guideline-directed anti-thrombotic therapy
- Able to understand and provide informed consent and comply with all study medications
Who cannot join
- Under the age of 18
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- Concurrent medical condition with a life expectancy of less than two years
- Haemodynamical unstable
- Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
Show all 14Show fewer
- Peridevice leak > 5mm as assessed immediately after LAAO or any other procedure-related complications
- Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted mechanical valve)
- Percutaneous coronary intervention (PCI) within 1 year.
- The patient had or is planning to have any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., PCI, cardioversion, cardiac surgery)
- Ongoing overt bleeding
- Previous stroke/TIA within 30 days of enrolment
- Symptomatic carotid artery disease
- Severe renal insufficiency (CrCl≤30ml/min/1.73m2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ling Tao
Xi'an, Shannxi, 710032
Chao Gao, M.D., Ph.D., +8618629551066, woshigaochao@gmail.com
About this study
Official title: Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial
The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Data from randomized trials, including PROTECT-AF, PREVAIL, and Prague-17, have suggested that LAAO has comparable efficacy to warfarin or NOACs. Considering these results, LAAO was recommended by the American College of Cardiology (ACC) and European Society of Cardiology (ESC) guidelines as a non-pharmacological stroke prevention strategy for patients with NVAF who have contraindications or are unsuitable for OAC.
The PROTECT-AF and PREVAIL trials stipulated the use of standardized antithrombotic medications which were designed to minimize the risk of stroke, systemic embolism, or device-related thrombosis. This antithrombotic strategy was subsequently endorsed by the guidelines, briefly, patients with LAAO were discharged on warfarin and aspirin for 45 days post-LAAO, if there was no leak or a leak ≤5 mm under transesophageal echocardiography (TEE) at 45-day follow-up, antithrombotic strategies shall switch to dual antiplatelet therapy (DAPT) until 6 months post-LAAO, and then aspirin thereafter.
Although LAAO was recommended by medical societies, previous patient-level meta-analyses have implied that compared with oral anticoagulation, LAAO had significantly more ischemic strokes, suggesting the inability of LAAO to prevent an ischemic stroke from sources beyond LAA. Will a combined strategy of LAAO and OAC further reduce the risk of stroke? The investigators hypothesized that a long-term low dose-Rivaroxaban (10mg daily) post-LAAO might be a potent supplement to the residue risk of ischemic stroke.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban 15mg, Aspirin 100mg, Clopidogrel 75mg, Rivaroxaban 10mg, Rivaroxaban 2.5mg
- Keywords
- Left atrial appendage occlusion, Anti-coagulation, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 15mgDrug
QD
Aspirin 100mgDrug
QD
Clopidogrel 75mgDrug
QD
Rivaroxaban 10mgDrug
QD
Rivaroxaban 2.5mgDrug
B.I.D
| Study group | Role | What they receive |
|---|---|---|
| Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy | Experimental | HAS-BLED<3: Rivaroxaban 15 mg QD for 3 months, followed by Rivaroxaban 10 mg QD indefinitely
HAS-BLED≥3: Rivaroxaban 10 mg QD for 3 months, followed by Rivaroxaban 2.5 mg bid indefinitely Receives: Drug: Rivaroxaban 15mg; Drug: Rivaroxaban 10mg; Drug: Rivaroxaban 2.5mg |
| Guideline determined medication therapy (GDMT) | Active comparator | HAS-BLED<3: Rivaroxaban 15 mg QD + Aspirin 100mg QD for 3 months, then Aspirin 100mg QD indefinitely
HAS-BLED≥3: Aspirin 100mg QD + Clopidogrel 75mg QD for 3 months, then Aspirin 100mg QD indefinitely Receives: Drug: Rivaroxaban 15mg; Drug: Aspirin 100mg; Drug: Clopidogrel 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the composite endpoint of any death, any stroke, systemic embolism, and The Bleeding Academic Research Consortium (BARC)-defined 3 or 5 bleeding events
Measured: 24 months post randomization
Secondary outcomes (19)
Rate of the composite endpoint of any death, any stroke, systemic embolism, and BARC defined 3 or 5 bleeding events
Measured: 45 days, 6, 12 months (Time-to-event)
Rate of the composite endpoint of any death, any stroke, systemic embolism
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of the BARC type 3 or 5 bleeding events
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of the composite endpoint of any death, any stroke, systemic embolism, myocardial infarction (MI)
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of any death
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of any stroke
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of systemic embolism
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of myocardial infarction (MI)
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 2, 3 or 5 bleeding events
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 2 bleeding events
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 3 bleeding events
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 5 bleeding events
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of GUSTO defined major bleeding and/or minor bleeding
Global Use of Strategies to Open Occluded Arteries, (GUSTO) defined major bleeding and/or minor bleeding
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of TIMI defined major bleeding and/or minor bleeding
Thrombolysis in Myocardial Infarction (TIMI) defined major bleeding and/or minor bleeding
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of ISTH defined major bleeding and/or clinically relevant minor bleeding
International Society on Thrombosis and Haemostasis (ISTH) defined major bleeding and/or clinically relevant minor bleeding
Measured: 45 days, 6, 12, 24 months (Time-to-event)
Rate of patient adherence to allocated medication
Adherence is defined as the participant who uses the medication strategies in this trial achieving 80% of the time on the therapeutic range
Measured: 45 days, 6, 12, 24 months (Binary)
Scores of the National Institutes of Health Stroke Scale (NIHSS) questionnaire
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: 45 days, 6, 12, 24 months (Continuous)
Scores of the Modified Rankin Scale (mRS)
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials.
Measured: 45 days, 6, 12, 24 months (Continuous)
Scores of the 5-level EQ-5D version (EQ-5D-5L) questionnaire
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 45 days, 6, 12, 24 months (Continuous)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Jul 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2028 (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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LingTao, Xijing Hospital
- Investigators
- Ling Tao, M.D., Ph.D., Study chair, Xijing HospitalChao Gao, M.D., Ph.D., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960721
- Sponsor's protocol ID
- RECORD-III
- Acronym
- RECORD-III
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial
- ClinicalTrials.gov ID
- NCT05960721
- Acronym / sponsor ID
- RECORD-III / RECORD-III
- Conditions
- Atrial Fibrillation
- Keywords
- Left atrial appendage occlusion, Anti-coagulation, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,220 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 27 Jul 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 increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Data from randomized trials, including PROTECT-AF, PREVAIL, and Prague-17, have suggested that LAAO has comparable efficacy to warfarin or NOACs. Considering these results, LAAO was recommended by the American College of Cardiology (ACC) and European Society of Cardiology (ESC) guidelines as a non-pharmacological stroke prevention strategy for patients with NVAF who have contraindications or are unsuitable for OAC.
The PROTECT-AF and PREVAIL trials stipulated the use of standardized antithrombotic medications which were designed to minimize the risk of stroke, systemic embolism, or device-related thrombosis. This antithrombotic strategy was subsequently endorsed by the guidelines, briefly, patients with LAAO were discharged on warfarin and aspirin for 45 days post-LAAO, if there was no leak or a leak ≤5 mm under transesophageal echocardiography (TEE) at 45-day follow-up, antithrombotic strategies shall switch to dual antiplatelet therapy (DAPT) until 6 months post-LAAO, and then aspirin thereafter.
Although LAAO was recommended by medical societies, previous patient-level meta-analyses have implied that compared with oral anticoagulation, LAAO had significantly more ischemic strokes, suggesting the inability of LAAO to prevent an ischemic stroke from sources beyond LAA. Will a combined strategy of LAAO and OAC further reduce the risk of stroke? The investigators hypothesized that a long-term low dose-Rivaroxaban (10mg daily) post-LAAO might be a potent supplement to the residue risk of ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy | Experimental | Drug: Rivaroxaban 15mg, Drug: Rivaroxaban 10mg, Drug: Rivaroxaban 2.5mgHAS-BLED<3: Rivaroxaban 15 mg QD for 3 months, followed by Rivaroxaban 10 mg QD indefinitely HAS-BLED≥3: Rivaroxaban 10 mg QD for 3 months, followed by Rivaroxaban 2.5 mg bid indefinitely |
| Guideline determined medication therapy (GDMT) | Active comparator | Drug: Rivaroxaban 15mg, Drug: Aspirin 100mg, Drug: Clopidogrel 75mgHAS-BLED<3: Rivaroxaban 15 mg QD + Aspirin 100mg QD for 3 months, then Aspirin 100mg QD indefinitely HAS-BLED≥3: Aspirin 100mg QD + Clopidogrel 75mg QD for 3 months, then Aspirin 100mg QD indefinitely |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-valvular atrial fibrillation (NVAF) patients with successful left atrial appendage occlusion (LAAO)
- Eligible for guideline-directed anti-thrombotic therapy
- Able to understand and provide informed consent and comply with all study medications
Key exclusion criteria (14 listed)
- Under the age of 18
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- Concurrent medical condition with a life expectancy of less than two years
- Haemodynamical unstable
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 |
|---|---|---|
| Rivaroxaban 15mgQD | Drug | Guideline determined medication therapy (GDMT), Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy |
| Aspirin 100mgQD | Drug | Guideline determined medication therapy (GDMT) |
| Clopidogrel 75mgQD | Drug | Guideline determined medication therapy (GDMT) |
| Rivaroxaban 10mgQD | Drug | Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy |
| Rivaroxaban 2.5mgB.I.D | Drug | Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy |
Primary outcome
Rate of the composite endpoint of any death, any stroke, systemic embolism, and The Bleeding Academic Research Consortium (BARC)-defined 3 or 5 bleeding events
Time frame: 24 months post randomization
19 secondary outcomes
Rate of the composite endpoint of any death, any stroke, systemic embolism, and BARC defined 3 or 5 bleeding events
Time frame: 45 days, 6, 12 months (Time-to-event)
Rate of the composite endpoint of any death, any stroke, systemic embolism
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of the BARC type 3 or 5 bleeding events
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of the composite endpoint of any death, any stroke, systemic embolism, myocardial infarction (MI)
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of any death
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of any stroke
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of systemic embolism
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of myocardial infarction (MI)
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 2, 3 or 5 bleeding events
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 2 bleeding events
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 3 bleeding events
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of BARC type 5 bleeding events
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of GUSTO defined major bleeding and/or minor bleeding
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of TIMI defined major bleeding and/or minor bleeding
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of ISTH defined major bleeding and/or clinically relevant minor bleeding
Time frame: 45 days, 6, 12, 24 months (Time-to-event)
Rate of patient adherence to allocated medication
Time frame: 45 days, 6, 12, 24 months (Binary)
Scores of the National Institutes of Health Stroke Scale (NIHSS) questionnaire
Time frame: 45 days, 6, 12, 24 months (Continuous)
Scores of the Modified Rankin Scale (mRS)
Time frame: 45 days, 6, 12, 24 months (Continuous)
Scores of the 5-level EQ-5D version (EQ-5D-5L) questionnaire
Time frame: 45 days, 6, 12, 24 months (Continuous)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Ling Tao, M.D., Ph.D. study chair
Xijing Hospital
Chao Gao, M.D., Ph.D. study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban 15mg, Aspirin 100mg and Clopidogrel 75mg in people with Atrial Fibrillation, run by Xijing 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 Jul 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Gao, M.D., Ph.D. (+86-18629551066, woshigaochao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of the composite endpoint of any death, any stroke, systemic embolism, and The Bleeding Academic Research Consortium (BARC)-defined 3 or 5 bleeding events (time frame: 24 months post randomization). 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 27 Jul 2023.