Coronary Artery DiseasePhase 4SWAP-ACNCT04006288

Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease

A Phase 4 study testing Clopidogrel, Prasugrel and ticagrelor in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Clopidogrel, Prasugrel and ticagrelor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2019to 16 May 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Willing and able to provide written informed consent
Above 18 years of age
Have known CAD and have completed their required duration of standard of care DAPT (aspirin in combination with either clopidogrel, prasugrel, or ticagrelor) and still be on treatment:
≥ 6 months after an elective PCI
≥ 12 months after experiencing an ACS (irrespective of revascularization at the time of ACS; thus patients treated by PCI, CABG, or medically managed can be considered)

Who cannot join

Deemed to be at high risk of bleeding, active bleeding or history of major bleeding Stroke within 1 month or any history of hemorrhagic or lacunar stroke
Estimated glomerular filtration rate <15 mL/min by MDRD equation
Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions.
History of hypersensitivity or known contraindication for rivaroxaban.
Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e.

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rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
Any known hepatic disease associated with coagulopathy
Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control (e.g. surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization)
Concomitant participation in another study with investigational drug
Known contraindication to any study related procedures
Hemoglobin ≤9 mg/dL
Platelet count <80x106/mL

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. The objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).

Read the detailed description

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. In the COMPASS trial, patients with stable coronary or peripheral artery disease and no indication for oral anticoagulation or dual antiplatelet therapy (DAPT) were randomized to rivaroxaban 2.5 mg bid in combination with aspirin, rivaroxaban 5 mg bid monotherapy or aspirin monotherapy. The study showed a significant 24% relative reduction in ischemic outcomes with rivaroxaban 2.5 mg bid plus aspirin combination strategy compared with aspirin alone. These observations have raised practical considerations on how to implement the results of the COMPASS trial in clinical practice particularly for patients who are completing a minimum duration of DAPT and contemplating between continuing with a DAPT regimen versus switching to a dual pathway inhibition (DPI) regimen with aspirin plus rivaroxaban. Therefore, the objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).

Conditions: Coronary Artery Disease
Being tested: Clopidogrel, Prasugrel, ticagrelor, aspirin, rivaroxaban
Keywords: dual antiplatelet therapy, rivaroxaban, pharmacodynamic
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClopidogrelDrug
Also called Plavix
Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
PrasugrelDrug
Also called Effient
Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
ticagrelorDrug
Also called brilinta
Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
aspirinDrug
all patients will remain on aspirin
rivaroxabanDrug
Also called xarelto
Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban

Study groups in NCT04006288
Study group	Role	What they receive
Aspirin and clopidogrel	Active comparator	aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days Receives: Drug: Clopidogrel; Drug: aspirin
Aspirin and rivaroxaban from aspirin and clopidogrel	Experimental	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days Receives: Drug: aspirin; Drug: rivaroxaban
Aspirin and prasugrel	Active comparator	aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days Receives: Drug: Prasugrel; Drug: aspirin
Aspirin and rivaroxaban from aspirin and prasugrel	Experimental	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days Receives: Drug: aspirin; Drug: rivaroxaban
Aspirin and ticagrelor	Active comparator	aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days Receives: Drug: ticagrelor; Drug: aspirin
Aspirin and rivaroxaban from aspirin and ticagrelor	Experimental	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days Receives: Drug: aspirin; Drug: rivaroxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)
The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201916 May 2022

First posted5 Jul 2019
Study start6 Sep 2019
Primary completion31 Jan 2022
Study completion16 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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
Model description: Patients treated with either aspirin (81mg/qd) plus clopidogrel, aspirin (81mg/qd) plus ticagrelor (90mg/bid), or aspirin (81mg/qd) plus prasugrel (10mg/bid) will be identified. Each cohort will be randomized 1:1 to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid). Patients randomized to DAPT will continue their guideline recommended DAPT regimens.
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04006288
Sponsor's protocol ID: IIS-RIVA02
Acronym: SWAP-AC
Status last verified: Apr 2023
First submitted: 25 Jun 2019
Last updated: 26 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ortega-Paz L, Thomas CD, Laudani C, Giordano S, Franchi F, Tunehag KR, Rollini F, Durukan S, Rossi JS, Farahmandsadr M, Stouffer GA, Been L, Keeley EC, Duarte JD, Beitelshees AL, Lee CR, Cavallari LH, Angiolillo DJ. Impact of Race on Profiles of Platelet Reactivity and Clinical Outcomes in Clopidogrel-Treated Participants. Clin Pharmacol Ther. 2026 Jan;119(1):168-178. doi: 10.1002/cpt.70045. Epub 2025 Aug 28.
PubMed 40875095
Ortega-Paz L, Franchi F, Rollini F, Galli M, Been L, Ghanem G, Shalhoub A, Ossi T, Rivas A, Zhou X, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Jennings LK, Angiolillo DJ. Switching from Dual Antiplatelet Therapy with Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition with Aspirin Plus Vascular-Dose Rivaroxaban: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study. Thromb Haemost. 2024 Mar;124(3):263-273. doi: 10.1055/a-2098-6639. Epub 2023 May 24.
PubMed 37224883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study
ClinicalTrials.gov ID: NCT04006288
Acronym / sponsor ID: SWAP-AC / IIS-RIVA02
Conditions: Coronary Artery Disease
Keywords: dual antiplatelet therapy, rivaroxaban, pharmacodynamic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Janssen, LP
Study start: 6 Sep 2019 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 16 May 2022 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 26 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. The objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).

Detailed description

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. In the COMPASS trial, patients with stable coronary or peripheral artery disease and no indication for oral anticoagulation or dual antiplatelet therapy (DAPT) were randomized to rivaroxaban 2.5 mg bid in combination with aspirin, rivaroxaban 5 mg bid monotherapy or aspirin monotherapy. The study showed a significant 24% relative reduction in ischemic outcomes with rivaroxaban 2.5 mg bid plus aspirin combination strategy compared with aspirin alone. These observations have raised practical considerations on how to implement the results of the COMPASS trial in clinical practice particularly for patients who are completing a minimum duration of DAPT and contemplating between continuing with a DAPT regimen versus switching to a dual pathway inhibition (DPI) regimen with aspirin plus rivaroxaban. Therefore, the objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: Patients treated with either aspirin (81mg/qd) plus clopidogrel, aspirin (81mg/qd) plus ticagrelor (90mg/bid), or aspirin (81mg/qd) plus prasugrel (10mg/bid) will be identified. Each cohort will be randomized 1:1 to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid). Patients randomized to DAPT will continue their guideline recommended DAPT regimens.

Arm	Type	Receives
Aspirin and clopidogrel	Active comparator	Drug: Clopidogrel, Drug: aspirinaspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Aspirin and rivaroxaban from aspirin and clopidogrel	Experimental	Drug: aspirin, Drug: rivaroxabanaspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and prasugrel	Active comparator	Drug: Prasugrel, Drug: aspirinaspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Aspirin and rivaroxaban from aspirin and prasugrel	Experimental	Drug: aspirin, Drug: rivaroxabanaspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and ticagrelor	Active comparator	Drug: ticagrelor, Drug: aspirinaspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
Aspirin and rivaroxaban from aspirin and ticagrelor	Experimental	Drug: aspirin, Drug: rivaroxabanaspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Willing and able to provide written informed consent
Above 18 years of age
Have known CAD and have completed their required duration of standard of care DAPT (aspirin in combination with either clopidogrel, prasugrel, or ticagrelor) and still be on treatment:

Key exclusion criteria (13 listed)

Deemed to be at high risk of bleeding, active bleeding or history of major bleeding Stroke within 1 month or any history of hemorrhagic or lacunar stroke
Estimated glomerular filtration rate <15 mL/min by MDRD equation
Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions.
History of hypersensitivity or known contraindication for rivaroxaban.

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
ClopidogrelAlso: PlavixPatients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban	Drug	Aspirin and clopidogrel
PrasugrelAlso: EffientPatients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban	Drug	Aspirin and prasugrel
ticagrelorAlso: brilintaPatients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban	Drug	Aspirin and ticagrelor
aspirinall patients will remain on aspirin	Drug	Aspirin and clopidogrel, Aspirin and prasugrel, Aspirin and rivaroxaban from aspirin and clopidogrel, Aspirin and rivaroxaban from aspirin and prasugrel, Aspirin and rivaroxaban from aspirin and ticagrelor, Aspirin and ticagrelor
rivaroxabanAlso: xareltoPatients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban	Drug	Aspirin and rivaroxaban from aspirin and clopidogrel, Aspirin and rivaroxaban from aspirin and prasugrel, Aspirin and rivaroxaban from aspirin and ticagrelor

Primary outcome

Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)
Time frame: 30 days
The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen

Results and safety

Results posted to the registry on 26 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aspirin and Clopidogrel	15	14
Aspirin and Rivaroxaban From Aspirin and Clopidogrel	15	14
Aspirin and Prasugrel	15	15
Aspirin and Rivaroxaban From Aspirin and Prasugrel	15	15
Aspirin and Ticagrelor	15	15
Aspirin and Rivaroxaban From Aspirin and Ticagrelor	15	15

Primary outcome: Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)

Time frame: 30 days. Median (Inter-Quartile Range). Unit: percentage of MPA

Measure	Aspirin and Clopidogrel n = 14	Aspirin and Rivaroxaban From Aspirin and Clopidogrel n = 14	Aspirin and Prasugrel n = 15	Aspirin and Rivaroxaban From Aspirin and Prasugrel n = 15	Aspirin and Ticagrelor n = 15	Aspirin and Rivaroxaban From Aspirin and Ticagrelor n = 15
Value	27 (17 to 50)	53 (43 to 66)	20 (4 to 37)	4 (0 to 17)	15 (1 to 33)	20 (6 to 50)

Adverse events

Time frame: At 30 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin and Clopidogrel	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Aspirin and Rivaroxaban From Aspirin and Clopidogrel	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Aspirin and Prasugrel	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Aspirin and Rivaroxaban From Aspirin and Prasugrel	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Aspirin and Ticagrelor	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Aspirin and Rivaroxaban From Aspirin and Ticagrelor	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40875095Ortega-Paz L, Thomas CD, Laudani C, Giordano S, Franchi F, Tunehag KR, Rollini F, Durukan S, Rossi JS, Farahmandsadr M, Stouffer GA, Been L, Keeley EC, Duarte JD, Beitelshees AL, Lee CR, Cavallari LH, Angiolillo DJ. Impact of Race on Profiles of Platelet Reactivity and Clinical Outcomes in Clopidogrel-Treated Participants. Clin Pharmacol Ther. 2026 Jan;119(1):168-178. doi: 10.1002/cpt.70045. Epub 2025 Aug 28.
Derived from this study: PubMed 37224883Ortega-Paz L, Franchi F, Rollini F, Galli M, Been L, Ghanem G, Shalhoub A, Ossi T, Rivas A, Zhou X, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Jennings LK, Angiolillo DJ. Switching from Dual Antiplatelet Therapy with Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition with Aspirin Plus Vascular-Dose Rivaroxaban: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study. Thromb Haemost. 2024 Mar;124(3):263-273. doi: 10.1055/a-2098-6639. Epub 2023 May 24.
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.

Dominick J Angiolillo, MD, PhD principal investigator

University of Florida

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 Clopidogrel, Prasugrel and ticagrelor in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.

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 13 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 26 Apr 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 United States. 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?

Yes. Results are posted in the registry (first posted 26 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA) (time frame: 30 days). 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 NCT04006288, which also lists 2 linked publications.

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 26 Apr 2023.