Atrial FibrillationPhase 2/3ADRIFTNCT03273322
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure
A Phase 2/3 study testing Rivaroxaban 10 mg qd, Rivaroxaban 15 mg qd and DAPT in people with Atrial Fibrillation and Atrial Appendage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Appendage, Hemorrhage
- What is being tested?
- Rivaroxaban 10 mg qd, Rivaroxaban 15 mg qd and DAPT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2017to 30 Sep 2019
- Phase
- Phase 2/3
- 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
- Men and women ≥18 years of age
- Patients who underwent a clinically successful LAAC procedure (device implanted without procedural or bleeding complication). LAAC may have been indicated for patients contraindicated or unsuitable for long-term Vitamin K antagonists (VKA) anticoagulation.
- AF (permanent or persistent or paroxysmal) patients irrespective of prior antithrombotic treatment are eligible for randomization.
- Written informed consent by the patient or designee if the patient is unable to consent
- Patients affiliated to the French social security system
Who cannot join
- Creatinine clearance <30 mL / min (Cockcroft formula).
- Dialysis.
- Mechanical heart valves or valvular disease requiring surgery or interventional procedure
- Planned Ablation of AF during follow up period
- Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk).
- Any contra-indication or known allergy to aspirin or clopidogrel or rivaroxaban.
Show all 20Show fewer
- Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism)
- Ongoing major bleeding or complicated or recent (<72hours) major surgery
- Known large oesophageal varices or decompensated liver disease (unless a documented positive opinion of a gastro-enterologist)
- Severe thrombocytopenia (<50,000/ml) after referral to haematologist to confirm or not contraindication
- Recent myocardial infarction (<6 weeks).
- Recent cerebro-vascular event (CVE) or transient ischemic attack (<6 weeks) after evaluation of stroke vs bleeding risk by the referring neurologist.
- Recent Intracranial bleeding (< 6 months): these patients will be evaluated by a neurologist as these patients may be considered at higher stroke risk. Neurologist may consider that the LAAC procedure with a short (90 days) period of anticoagulation or antiplatelet therapy as tested in the protocol is a preferable option (in that case intracranial hemorrhage (ICH) will not be considered as a contraindication).
- Prasugrel or ticagrelor concomitant use
- Participating in an investigational drug or another device trial within the previous 30 days.
- High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical.
- Woman with child bearing potential who do not use an efficient method of contraception.
- positive serum or urine pregnancy test for woman with child bearing potential
- Pregnancy or within 48 hours post-partum or breast feeding women
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure: The Randomized ADRIFT Study
Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.
Read the detailed description
Data on antithrombotic therapy after Left Atrial Appendage Closure (LAAC) are scarce and no randomized evaluation has been performed to demonstrate what is the best antithrombotic strategy following LAAC. LAAC is classically associated with a 6-week period of anticoagulation with warfarin + aspirin followed by once daily clopidogrel (75 mg) + aspirin (81-325 mg) until the 6 months visit, then aspirin alone is continued indefinitely, as tested in patients without contraindication for anticoagulation in the pivotal Watchman trials. LAAC is mostly used in Europe as an alternative to warfarin anticoagulation when patients have a contraindication to or are unsuitable for warfarin anticoagulation. The classic regimen is not applicable and believed to be too risky in such frail patients. These patients usually receive a regimen of daily clopidogrel + aspirin followed by single antiplatelet therapy (most frequently used treatment). Some patients receive oral anticoagulation without aspirin, including NOAC anticoagulation. Rivaroxaban is a tempting strategy for anticoagulation following LAAC in atrial fibrillation (AF) patients. The dose needs first to be carefully evaluated the trial propose a dose ranging study in patients who have undergone successful LAAC.
The study will evaluate two different Rivaroxaban regimen (10 or 15 mg a day) in comparison to dual antiplatelet therapy (DAPT) (aspirin+clopidogrel : control arm representing standard of care) after successful LAAC. The aim is to investigate whether rivaroxaban could provide correct anticoagulation levels and adequately suppress coagulation activation after LAAC.
The patient will be enrolled after left atrial appendage closure before discharge. The randomization is 1/1/1 between the 3 groups : rivaroxaban 10mg a day, rivaroxaban 15 mg a day and aspirin 75mg + clopidogrel 75 mg a day. At 10 and 90 days, the patients will be sampled for biological assessment : Prothrombin fragments 1+2, Factor Xa inhibitory activity, Russel Viper venom enzyme assay, thrombin anti-thrombin (TAT) complex, D-Dimers, Prothrombin time (Neoplastin) and plasma von Willebrand factor (vWf) Ag level
After 90 days, the patient will end his/her participation in the trial. Clinical endpoints (death, MI, Stroke, TIA, systemic embolism, extracranial major bleeding or clinically relevant non major bleeding) at 90 days will be assessed by a clinical endpoint committee. Central echographic laboratory will review all 90 days transesophageal echocardiography (TEE) to detect the presence of thrombus or peri-device leak.
The study is open-label. Central laboratory, clinical endpoint committee and echographic core laboratory is blinded to randomization arm.
- Conditions
- Atrial Fibrillation, Atrial Appendage, Hemorrhage
- Being tested
- Rivaroxaban 10 mg qd, Rivaroxaban 15 mg qd, DAPT
- Keywords
- Left atrial appendage closure, Rivaroxaban, Dual antiplatelet therapy, Anticoagulation, Stroke prevention
- Medical subject headings
- Atrial Fibrillation, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 mg qdDrug
Also called Experimental
10mg qd
Rivaroxaban 15 mg qdDrug
Also called Experimental
15mg qd
DAPTDrug
Also called Active comparator
Aspirin 75 mg qd + Clopidogrel 75 mg qd
| Study group | Role | What they receive |
|---|---|---|
| 1: Rivaroxaban 10 mg qd | Experimental | Rivaroxaban 10 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM Receives: Drug: Rivaroxaban 10 mg qd |
| 2: Rivaroxaban 15 mg qd | Experimental | Rivaroxaban 15 mg, 1 tablet a day, from randomization to Day 90
should be taken between 8 and 10 AM Receives: Drug: Rivaroxaban 15 mg qd |
| 3: DAPT | Active comparator | Aspirin 75 mg, 1 a day Clopidogrel 75 mg, 1 tablet a day from randomization to Day 90 should be taken between 8 and 10 AM Receives: Drug: DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of prothrombin fragment 1 + 2
Measure of prothrombin fragment 1 + 2 at Day 10 (2 to 4 hours after last intake : concentration peak)
Measured: at Day 10
Secondary outcomes (20)
Measure of prothrombin fragment 1 + 2
Measure of prothrombin fragment 1 + 2 at Day 90 (2 to 4 hours after last intake : concentration peak)
Measured: at Day 90
Factor Xa inhibitory activity at day 10
Factor Xa inhibitory activity
Measured: at Day 10
Factor Xa inhibitory activity at day 90
Factor Xa inhibitory activity
Measured: at Day 90
Russel Viper venom enzyme assay
Russel Viper venom enzyme assay
Measured: at Day 90
TAT complex
TAT complex
Measured: at Day 10
TAT complex
TAT complex
Measured: at Day 90
D-Dimers
D-Dimersand at peak, 2 to 4 hours after treatment intake
Measured: at Day 10
D-Dimers
D-Dimersand at peak, 2 to 4 hours after treatment intake
Measured: at Day 90
Prothrombin time (Neoplastin)
Prothrombin time (Neoplastin)
Measured: at Day 10
Prothrombin time (Neoplastin)
Prothrombin time (Neoplastin)
Measured: at Day 90
Plasma vWf Ag level
plasma vWf Ag level treatment intake
Measured: at Day 10
Plasma vWf Ag level
plasma vWf Ag level treatment intake
Measured: at Day 90
Haemorrhagic stroke and bleeding will be safety outcomes TEE with central core lab reading: presence of thrombus, peri-device leak
Haemorrhagic stroke and bleeding will be safety outcomes 3-month TEE with central core lab reading: presence of thrombus, peri-device leak
Measured: at Day 90
Composite clinical endpoint combining all clinical outcomes
Composite clinical endpoint combining all clinical outcomes : Death, MI, stroke, TIA,
Measured: at Day 90
Death (any cause)
Death (any cause) assessed individually and combined at other outcomes
Measured: at Day 90
Myocardial infarction (MI)
Myocardial infarction (MI) assessed individually and combined at other outcomes
Measured: at Day 90
Stroke (ischaemic stroke, haemorrhagic stroke)
Stroke (ischaemic stroke, haemorrhagic stroke) assessed individually and combined at other outcomes
Measured: at Day 90
Transient Ischemic Attack (TIA)
Transient Ischemic Attack (TIA) assessed individually and combined at other outcomes
Measured: at Day 90
Systemic embolism
Systemic embolism assessed individually and combined at other outcomes
Measured: at Day 90
Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) at day 90
Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) assessed individually and combined at other outcomes
Measured: at Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start13 Sep 2017
- Primary completion20 Nov 2018
- Study completion30 Sep 2019
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 Assistance Publique - Hôpitaux de ParisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Action Research Group, Bayer
- Responsible party
- Sponsor
- Investigators
- Gilles MONTALESCOT, MD, PhD, Principal investigator, Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273322
- Sponsor's protocol ID
- P161102J
- Acronym
- ADRIFT
- Status last verified
- Nov 2021
- First submitted
- 11 Aug 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duthoit G, Silvain J, Marijon E, Ducrocq G, Lepillier A, Frere C, Dimby SF, Popovic B, Lellouche N, Martin-Toutain I, Spaulding C, Brochet E, Attias D, Mansourati J, Lorgis L, Klug D, Zannad N, Hauguel-Moreau M, Braik N, Deltour S, Ceccaldi A, Wang H, Hammoudi N, Brugier D, Vicaut E, Juliard JM, Montalescot G. Reduced Rivaroxaban Dose Versus Dual Antiplatelet Therapy After Left Atrial Appendage Closure: ADRIFT a Randomized Pilot Study. Circ Cardiovasc Interv. 2020 Jul;13(7):e008481. doi: 10.1161/CIRCINTERVENTIONS.119.008481. Epub 2020 Jul 17.
PubMed 32674675
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure: The Randomized ADRIFT Study
- ClinicalTrials.gov ID
- NCT03273322
- Acronym / sponsor ID
- ADRIFT / P161102J
- Conditions
- Atrial Fibrillation, Atrial Appendage, Hemorrhage
- Keywords
- Left atrial appendage closure, Rivaroxaban, Dual antiplatelet therapy, Anticoagulation, Stroke prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Action Research Group, Bayer
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Sep 2017 (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.
Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.
Detailed description
Data on antithrombotic therapy after Left Atrial Appendage Closure (LAAC) are scarce and no randomized evaluation has been performed to demonstrate what is the best antithrombotic strategy following LAAC. LAAC is classically associated with a 6-week period of anticoagulation with warfarin + aspirin followed by once daily clopidogrel (75 mg) + aspirin (81-325 mg) until the 6 months visit, then aspirin alone is continued indefinitely, as tested in patients without contraindication for anticoagulation in the pivotal Watchman trials. LAAC is mostly used in Europe as an alternative to warfarin anticoagulation when patients have a contraindication to or are unsuitable for warfarin anticoagulation. The classic regimen is not applicable and believed to be too risky in such frail patients. These patients usually receive a regimen of daily clopidogrel + aspirin followed by single antiplatelet therapy (most frequently used treatment). Some patients receive oral anticoagulation without aspirin, including NOAC anticoagulation. Rivaroxaban is a tempting strategy for anticoagulation following LAAC in atrial fibrillation (AF) patients. The dose needs first to be carefully evaluated the trial propose a dose ranging study in patients who have undergone successful LAAC.
The study will evaluate two different Rivaroxaban regimen (10 or 15 mg a day) in comparison to dual antiplatelet therapy (DAPT) (aspirin+clopidogrel : control arm representing standard of care) after successful LAAC. The aim is to investigate whether rivaroxaban could provide correct anticoagulation levels and adequately suppress coagulation activation after LAAC.
The patient will be enrolled after left atrial appendage closure before discharge. The randomization is 1/1/1 between the 3 groups : rivaroxaban 10mg a day, rivaroxaban 15 mg a day and aspirin 75mg + clopidogrel 75 mg a day. At 10 and 90 days, the patients will be sampled for biological assessment : Prothrombin fragments 1+2, Factor Xa inhibitory activity, Russel Viper venom enzyme assay, thrombin anti-thrombin (TAT) complex, D-Dimers, Prothrombin time (Neoplastin) and plasma von Willebrand factor (vWf) Ag level
After 90 days, the patient will end his/her participation in the trial. Clinical endpoints (death, MI, Stroke, TIA, systemic embolism, extracranial major bleeding or clinically relevant non major bleeding) at 90 days will be assessed by a clinical endpoint committee. Central echographic laboratory will review all 90 days transesophageal echocardiography (TEE) to detect the presence of thrombus or peri-device leak.
The study is open-label. Central laboratory, clinical endpoint committee and echographic core laboratory is blinded to randomization arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Rivaroxaban 10 mg qd | Experimental | Drug: Rivaroxaban 10 mg qdRivaroxaban 10 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM |
| 2: Rivaroxaban 15 mg qd | Experimental | Drug: Rivaroxaban 15 mg qdRivaroxaban 15 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM |
| 3: DAPT | Active comparator | Drug: DAPTAspirin 75 mg, 1 a day Clopidogrel 75 mg, 1 tablet a day from randomization to Day 90 should be taken between 8 and 10 AM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ≥18 years of age
- Patients who underwent a clinically successful LAAC procedure (device implanted without procedural or bleeding complication). LAAC may have been indicated for patients contraindicated or unsuitable for long-term Vitamin K antagonists (VKA) anticoagulation.
- AF (permanent or persistent or paroxysmal) patients irrespective of prior antithrombotic treatment are eligible for randomization.
- Written informed consent by the patient or designee if the patient is unable to consent
- Patients affiliated to the French social security system
Key exclusion criteria (20 listed)
- Creatinine clearance <30 mL / min (Cockcroft formula).
- Dialysis.
- Mechanical heart valves or valvular disease requiring surgery or interventional procedure
- Planned Ablation of AF during follow up period
- Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk).
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 10 mg qdAlso: Experimental10mg qd | Drug | 1: Rivaroxaban 10 mg qd |
| Rivaroxaban 15 mg qdAlso: Experimental15mg qd | Drug | 2: Rivaroxaban 15 mg qd |
| DAPTAlso: Active comparatorAspirin 75 mg qd + Clopidogrel 75 mg qd | Drug | 3: DAPT |
Primary outcome
Measure of prothrombin fragment 1 + 2
Time frame: at Day 10
Measure of prothrombin fragment 1 + 2 at Day 10 (2 to 4 hours after last intake : concentration peak)
20 secondary outcomes
Measure of prothrombin fragment 1 + 2
Time frame: at Day 90
Factor Xa inhibitory activity at day 10
Time frame: at Day 10
Factor Xa inhibitory activity at day 90
Time frame: at Day 90
Russel Viper venom enzyme assay
Time frame: at Day 90
TAT complex
Time frame: at Day 10
TAT complex
Time frame: at Day 90
D-Dimers
Time frame: at Day 10
D-Dimers
Time frame: at Day 90
Prothrombin time (Neoplastin)
Time frame: at Day 10
Prothrombin time (Neoplastin)
Time frame: at Day 90
Plasma vWf Ag level
Time frame: at Day 10
Plasma vWf Ag level
Time frame: at Day 90
Haemorrhagic stroke and bleeding will be safety outcomes TEE with central core lab reading: presence of thrombus, peri-device leak
Time frame: at Day 90
Composite clinical endpoint combining all clinical outcomes
Time frame: at Day 90
Death (any cause)
Time frame: at Day 90
Myocardial infarction (MI)
Time frame: at Day 90
Stroke (ischaemic stroke, haemorrhagic stroke)
Time frame: at Day 90
Transient Ischemic Attack (TIA)
Time frame: at Day 90
Systemic embolism
Time frame: at Day 90
Extracranial major bleeding or clinically relevant non major bleeding (ISTH definition) at day 90
Time frame: at Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Derived from this study: PubMed 32674675Duthoit G, Silvain J, Marijon E, Ducrocq G, Lepillier A, Frere C, Dimby SF, Popovic B, Lellouche N, Martin-Toutain I, Spaulding C, Brochet E, Attias D, Mansourati J, Lorgis L, Klug D, Zannad N, Hauguel-Moreau M, Braik N, Deltour S, Ceccaldi A, Wang H, Hammoudi N, Brugier D, Vicaut E, Juliard JM, Montalescot G. Reduced Rivaroxaban Dose Versus Dual Antiplatelet Therapy After Left Atrial Appendage Closure: ADRIFT a Randomized Pilot Study. Circ Cardiovasc Interv. 2020 Jul;13(7):e008481. doi: 10.1161/CIRCINTERVENTIONS.119.008481. Epub 2020 Jul 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.
Gilles MONTALESCOT, MD, PhD principal investigator
Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rivaroxaban 10 mg qd, Rivaroxaban 15 mg qd and DAPT in people with Atrial Fibrillation and Atrial Appendage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 20 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: finished, as of the sponsor's last update on 21 Dec 2021. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of prothrombin fragment 1 + 2 (time frame: at Day 10). 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 NCT03273322, 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 21 Dec 2021.