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Atrial FibrillationBLITZ-AFCancerNCT03909386

Non-interventional Study on Patients With Atrial Fibrillation and Cancer

An observational study of Atrial Fibrillation and Cancer, run by Heart Care Foundation at 147 sites in 6 countries.

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

AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Cancer
How many people
1,514 participants
Where
147 sitesin 6 countries
Study dates
26 Jun 2019to 30 Sep 2022
Phase
Observational
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

Study population: Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment) and with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented.

Who may be able to join

  • Both sexes
  • Age >18 years
  • Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment)
  • Patient with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented.
  • Written informed consent (IC) for participation in the study
  • Patient not simultaneously participating in any interventional study.

Who cannot join

  • -

Trial locations and contacts

147 sites in 6 countries.

147 sites in 6 countries

Italy100 sites

  • Ospedale Miulli - U.O.C. Cardiologia - Utic

    Acquaviva delle Fonti

  • Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic

    Agrigento, AG, 92100

  • Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia

    Alcamo, TP, 91011

  • Ospedale San Donato - U.O. Cardiologia

    Arezzo, AR, 52100

  • Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic

    Ariccia, RM, 00072

  • Ospedale Civile - U.O.C. Cardiologia

    Arzignano, VI, 36071

  • Ospedale E. Muscatello - U.O. Di Cardiologia - Utic

    Augusta, SR, 96011

  • Centro Di Riferimento Oncologico (Cro) - Cardiologia

    Aviano, PN, 33081

  • Ospedale San Paolo - Cardiologia-Utic

    Bari, BA, 70123

  • Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia

    Bari, BA, 70124

  • Ospedale Civile - Sc Cardiologia

    Belluno, BL, 32100

  • Ospedale Maggiore - U.O. Di Cardiologia

    Bologna, BO, 40133

  • Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi

    Bologna, BO, 40138

  • Ospedale Bellaria - U.O. Di Cardiologia

    Bologna, BO, 40139

  • Ospedale Ss. Trinita' - S.C. Di Cardiologia

    Borgomanero, 28021

  • Ospedale A. Businco - Servizio Di Cardiologia

    Cagliari, CA, 09121

  • Ospedale Roberto Binaghi - Servizio Di Cardiologia

    Cagliari, CA, 09126

  • Ospedale Barone Lombardo - Cardiologia E Utic

    Canicattì, AG, 92024

  • Ospedale Ramazzini - U.O. Cardiologia

    Carpi, MO, 41013

  • Ospedale Santo Spirito - Sc Cardiologia

    Casale Monferrato, AL, 15033

  • Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic

    Caserta, CE, 81100

  • Az. Ospedaliera S. Anna E S. Sebastiano - Uoc Medicina E Chirurgia D'Urgenza

    Caserta

  • Ospedale Di Castellaneta - S.C. Cardiologia

    Castellaneta, TA, 74011

  • Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic

    Castrovillari, CS, 87012

  • P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia

    Catania, CT, 95122

  • Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica

    Catania, CT, 95126

  • Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia

    Catania, CT, 95126

  • Fondazione G. Giglio - U.O. Cardiologia E Utic

    Cefalù, PA, 90015

  • Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii

    Chieti

  • Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic

    Copertino, LE, 73043

  • Ospedale Civile San Giuseppe - Cardiologia

    Empoli, FI, 50053

  • Ospedale Civile Profili - U.O. Cardiologia

    Fabriano, AN, 60044

  • Ospedale Santa Maria Del Prato - U.O. Di Cardiologia

    Feltre, BL, 32032

  • Arcispedale Sant'Anna - U.O. Cardiologia - Utic

    Ferrara

  • Ospedale San Giovanni Di Dio - Cardiologia

    Florence, FI, 50124

  • Aou Careggi - Cardiologa Diagnostica

    Florence, FI, 50134

  • Aou Careggi - Diagnostica Cardiovascolare

    Florence, FI, 50139

  • Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic

    Foggia, FG, 71100

  • Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari

    Genova, GE, 16132

  • Ospedale Padre Antero Micone - Sc Cardiologia - Utic

    Genova, GE, 16153

  • Ospedale Generale Di Zona - U.O. Cardiologia - Utic

    Giugliano in Campania, 80014

  • Ospedale Civile - Sc Cardiologia Area Nord

    Guastalla, RE, 42016

  • Nuovo Ospedale Versilia - Sc Cardiologia

    Lido di Camaiore, LU, 55043

  • Ospedale Civile M. Giannuzzi - Cardiologia E Utic

    Manduria, TA, 74024

  • Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia

    Martina Franca, TA, 74015

  • Policlinico G. Martino - U.O. Medicina Interna

    Messina, ME, 98124

  • Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia

    Milan, MI, 20133

  • Istituto Europeo Di Oncologia - Cardiologia

    Milan, MI, 20141

  • Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa

    Milan, MI, 20162

  • Ospedale Civile - U.O. Cardiologia

    Mirano, VE, 30035

  • Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic

    Mondovì, CN, 12084

  • Fondazione Pascale - S.C. Cardiologia

    Naples, 80131

  • Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.

    Naples, 80136

  • Ospedale Sacro Cuore - U.O. Di Cardiologia

    Negrar, VR, 37024

  • Aou Maggiore Della Carita' - Cardiologia Ii

    Novara, 28100

  • Ospedale San Francesco - Cardiologia - Utic

    Nuoro, NU, 08100

  • Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia

    Orbassano, TO, 10043

  • Istituto Oncologico Veneto - Cardiologia Oncologica

    Padova, PD, 35128

  • Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello

    Palermo, PA, 90146

  • Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia

    Paola, CS, 87027

  • Fondazione Irccs Policlinico San Matteo - Cardiologia

    Pavia, PV, 27100

  • Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica

    Pavia, PV, 27100

  • Presidio Ospedaliero San Salvatore - Cardiologia E Utic

    Pesaro, PU, 61121

  • Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica

    Pescara, PE, 65124

  • Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic

    Pescia

  • Ospedale Civile E. Agnelli - Sc Di Cardiologia

    Pinerolo, TO, 10064

  • Azienda Ospedaliera Universitaria Pisana - U.O. Malattie Cardiovasc. I - Cisanello

    Pisa, PI, 26124

  • Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic

    Poggibonsi, SI, 53036

  • Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic

    Polistena, RC, 89024

  • Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic

    Pozzuoli, 80078

  • Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic

    Ragusa, RG, 97100

  • Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia

    Ravenna, RA, 48100

  • Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia

    Reggio Calabria, RC, 89124

  • Arcispedale Santa Maria Nuova - S.C. Cardiologia

    Reggio Emilia, RE, 42100

  • Ospedale G. Ceccarini - Cardiologia-Utic

    Riccione, RN, 47838

  • Ospedale Degli Infermi, Sc Cardiologia

    Rivoli, TO

  • Campus Biomedico - Cardiologia

    Roma, RM, 00128

  • P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic

    Roma, RM, 00135

  • Ospedale San Camillo - Uosd Servizi Cardiologici Integrati

    Roma, RM, 00151

  • Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia

    Roma, RM, 00152

  • Policlinico Agostino Gemelli - Uo Cardiologia Per Sc E Riab. Cardiolog.

    Roma, RM, 00168

  • Ospedale Sandro Pertini, Uoc Cardiologia

    Roma

  • Ospedale Santa Maria Del Carmine - Cardiologia

    Rovereto, TN, 38068

  • Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva

    Salerno, SA, 84131

  • Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic

    Santa Maria Capua Vetere, CE, 81055

  • Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia

    Saronno, VA, 21047

  • Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa

    Sarzana, SP, 19038

  • Ospedale Di Sassuolo - Cardiologia

    Sassuolo, MO, 41049

  • Ospedale Maggiore Ss. Annunziata - Sc Cardiologia

    Savigliano, CN, 12038

  • Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

    Scorrano, LE, 73020

  • Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica

    Teramo, TE, 64100

  • Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia

    Terni, TR, 05100

  • Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia

    Torino, TO, 10126

  • Ospedale Mauriziano Umberto I - Sc Cardiologia

    Torino, TO, 10128

  • Ospedale Humanitas Gradenigo - Cardiologia

    Torino, TO, 10153

  • Ospedale Giovanni Bosco - Sc Cardiologia

    Torino, TO, 10155

  • Ospedali Treviglio-Caravaggio - Cardiologia

    Treviglio, BG, 24047

  • Asui Trieste - S.C. Centro Cardiovascolare

    Trieste, TS, 34125

  • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia

    Udine, UD, 33100

  • Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc

    Vizzolo Predabissi, MI, 20077

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  • Clínica Medicentro, Cardiología

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  • Hospital Rúber Internacional, Oncología

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  • Hospital Universitario Gregorio Marañón, Servicio de Cardiología

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  • Hospital Virgen de Arrixaca - Cardiologia

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  • Hospital de Salamanca, Cardiología

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  • Hospital Universitario Virgen Macarena, Cardiologia

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  • Hospital Universitario Río Hortega, Cardiología

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  • UCL Cliniques universitaires Saint-Luc - Cardiolgy

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  • Martini Ziekenhuis - Dept. Cardio Research Noord BV

    Groningen

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Portugal5 sites

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About this study

Official title: Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)

AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified.

A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.

Read the detailed description

International, multicenter, non-interventional study on patients with atrial fibrillation (AF) and cancer (diagnosed within the last 3 years prior to enrolment).

The study will be conducted in about 80 sites in italy and 50 sites distributed in other European countries (Belgium, Germany, Ireland, Portugal, Spain, The Netherlands, Turkey).

The study will continue till the consecutive recruitment of 1500 patients. The recruitment period will last approximately 24 months.

Number of visits per patient: Baseline and 1 year (Final). Physicians will not be required to perform any additional tests, assessments, etc., not in line with their routine medical practice.

Medical subject headings
Atrial Fibrillation, Neoplasms

What is being measured

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

  1. Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Measured: Baseline

  2. Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Measured: 12 Months

Secondary outcomes (19)

  1. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke

    Measured: Baseline and 12 months

  2. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks

    Measured: Baseline and 12 months

  3. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death)

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death)

    Measured: Baseline and 12 months

  4. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events

    Measured: Baseline and 12 months

  5. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome

    Measured: Baseline and 12 months

  6. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism

    Measured: Baseline and 12 months

  7. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis

    Measured: Baseline and 12 months

  8. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism

    Measured: Baseline and 12 months

  9. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage

    Measured: Baseline and 12 months

  10. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding

    Measured: Baseline and 12 months

  11. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding

    Measured: Baseline and 12 months

  12. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death

    Measured: Baseline and 12 months

  13. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death

    Measured: Baseline and 12 months

  14. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy

    Measured: Baseline and 12 months

  15. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death

    Measured: Baseline and 12 months

  16. Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes

    Number of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes

    Measured: Baseline and 12 months

  17. Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes

    Length of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes;

    Measured: Baseline and 12 months

  18. Treatment satisfaction

    Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q)

    Measured: Baseline and 12 months

  19. Quality of life satisfaction

    Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire

    Measured: Baseline and 12 months

Timeline

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

  1. First posted10 Apr 2019
  2. Study start26 Jun 2019
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03909386
Sponsor's protocol ID
K21
Acronym
BLITZ-AFCancer
Status last verified
Jan 2023
First submitted
5 Apr 2019
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gulizia MM, Turazza FM, Ameri P, Alings M, Collins R, De Luca L, Di Nisio M, Lucci D, Gabrielli D, Janssens S, Parrini I, Pinto FJ, Zamorano J, Colivicchi F; BLITZ-AF Cancer Investigators. Characteristics and Management of Patients With Cancer and Atrial Fibrillation: The BLITZ-AF Cancer Registry. JACC Adv. 2024 May 24;3(7):100991. doi: 10.1016/j.jacadv.2024.100991. eCollection 2024 Jul.

    PubMed 39130025

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Cancer, run by Heart Care Foundation at 147 sites in 6 countries.

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 6 inclusion and 1 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 12 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 147 sites in Italy, Spain, Belgium, Netherlands, Portugal and 1 more country. 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?

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?

Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy (time frame: Baseline). 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?

On the ClinicalTrials.gov record for NCT03909386, 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 12 Jan 2023.

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