Coronary DiseasePhase 4NCT00242944

Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)

A Phase 4 study testing Pitavastatin and Atorvastatin in people with Coronary Disease and Hypercholesterolemia, run by Kyoto University at 3 sites in Japan.

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

The purpose of this study is to compare the effects of pitavastatin and atorvastatin on coronary plaque volume in patients with acute coronary syndrome and to clarify the relationship between coronary plaque volume, serum lipids, and inflammation markers in order to determine the significance of intensive lipid… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Coronary Disease, Hypercholesterolemia
What is being tested?: Pitavastatin and Atorvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 307 participants
Where: 3 sitesJapan
Study dates: Nov 2005to Mar 2008
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial
Patients 20 years or older at the time of their consent
Patients with hypercholesterolemia as defined by any of the following criteria:
TC >= 220 mg/dL;
LDL-C >= 140 mg/dL;
Cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C >= 100 mg/dL or TC >= 180 mg/dL.

Show all 9Show fewer

Patients who have been diagnosed with acute coronary syndrome
Patients with successful percutaneous coronary intervention (PCI) by intravascular ultrasound (IVUS) guidance
Patients having coronary plaques (>= 500 µm in thickness or 20% or more in % plaque) at >= 5 mm from the previously treated area in the same branch of coronary artery

Who cannot join

Patients with bypass graft or in-stent restenosis at the site of PCI
Patients who had received PCI on the lesion in the past where the evaluation of coronary plaque volume is planned
Patients who had plaques in a non-culprit site and might receive PCI during the treatment period
Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors)
Patients with familial hypercholesterolemia
Patients with cardiogenic shock

Show all 12Show fewer

Patients receiving cyclosporine
Patients with any allergy to pitavastatin or atorvastatin
Patients with hepatobiliary disorders
Pregnant women, women suspected of being pregnant, or lactating women
Patients with renal disorders or undergoing dialysis
Patients who are ineligible in the opinion of the investigator

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Juntendo University School of Medicine
Bunkyo-ku, Tokyo, 113-8421
Kyoto University Graduate School of Medicine
Kyoto, 606-8507
Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, 755-8505

Other trials in Japan

About this study

Official title: Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome

Read the detailed description

Previous mega trials have demonstrated that lipid lowering therapy with HMG-CoA reductase inhibitors (statins) reduces the incidence of major cardiovascular events by one-third, thus, the benefit of lipid lowering therapy has been substantiated. Such a benefit is significant especially for patients with coronary heart disease (CHD). The third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP-III) has suggested the advantage of more intensive lipid lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal for patients with coronary heart disease should be below 100 mg/dL. However, there is no satisfactory evidence yet for the need to lower LDL-C level less than the goal prescribed in Japan.

Recently, research on diagnosis of coronary plaque has shown significant advances. The REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound, suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was associated with no growth of plaque (-0.4% compared to baseline), versus therapy with pravastatin (40 mg/day) which showed a slight increase (2.7%) in plaque volume over 18 months. In Japan, the ESTABLISH study, a single center study, indicated that early intensive lipid lowering therapy with atorvastatin (20 mg/day) could induce a significant reduction in plaque volume in patients with acute coronary syndrome. However, this benefit has not been verified in multicenter trials in Japan. Further, no comparative investigation into the effect of various concomitant drugs on coronary plaque has been done.

Pitavastatin is a chemically synthesized statin in Japan which has been marketed since late 2003. Pitavastatin has an LDL-C lowering effect as strong as atorvastatin and also has a superior HDL-C elevating effect; meanwhile, the effect of pitavastatin on coronary plaque has not been reported.

Conditions: Coronary Disease, Hypercholesterolemia
Being tested: Pitavastatin, Atorvastatin
Keywords: Acute coronary syndrome, Hypercholesterolemia, Primary coronary intervention, Hydroxymethylglutaryl-CoA reductase inhibitors, coronary plaque, Angioplasty, Transluminal, Percutaneous Coronary, Ultrasonography, Interventional
Medical subject headings: Coronary Disease, Hypercholesterolemia, Acute Coronary Syndrome

What participants receive

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

PitavastatinDrug
Pitavastatin 4mg per day
AtorvastatinDrug
Atorvastatin 20mg per day

Study groups in NCT00242944
Study group	Role	What they receive
1	Active comparator	Pitavastatin Receives: Drug: Pitavastatin
2	Active comparator	Atorvastatin Receives: Drug: Atorvastatin

What is being measured

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

plaque volume
Measured: one year

Secondary outcomes (24)

total cholesterol (TC)
Measured: one year
low-density lipoprotein (LDL)-cholesterol (LDL-C)
Measured: one year
high-density lipoprotein (HDL)-cholesterol (HDL-C)
Measured: one year
HDL2-C
Measured: one year
HDL3-C
Measured: one year
remnant like particles-cholesterol (RLP-C)
Measured: one year
small dense LDL-C
Measured: one year
non-HDL-C
Measured: one year
LDL-C/HDL-C
Measured: one year
apolipoprotein AI (apoA-I)
Measured: one year
apoB
Measured: one year
apoE
Measured: one year
apoB/apoA-I
Measured: one year
malondialdehyde-modified LDL (MDA-LDL)
Measured: one year
phospholipids
Measured: one year
lipoprotein(a) [Lp(a)]
Measured: one year
high-sensitivity C-reactive protein (hs-CRP)
Measured: one year
pentraxin 3
Measured: one year
leukocytes
Measured: one year
coronary plaque area at culprit region
Measured: one year
minimal lumen diameter (MLD) and percent (%) stenosis
Measured: one year
major adverse cardiac events (cardiac death, Q or non-Q myocardial infarction and target vessel revascularization)
Measured: one year
number of deaths from any cause
Measured: one year
frequency of adverse drug reactions
Measured: one year

Timeline

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

Nov 2005Mar 2008

First posted21 Oct 2005 (estimated)
Study startNov 2005
Primary completionOct 2007
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Coronary DiseaseStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00242944
Sponsor's protocol ID: H17-49
Status last verified: Oct 2023
First submitted: 20 Oct 2005
Last updated: 4 Oct 2023
Results posted: No
Data monitoring committee: Yes

Publications

Miyauchi K, Kimura T, Morimoto T, Nakagawa Y, Yamagishi M, Ozaki Y, Hiro T, Daida H, Matsuzaki M. Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome (JAPAN-ACS): rationale and design. Circ J. 2006 Dec;70(12):1624-8. doi: 10.1253/circj.70.1624.
PubMed 17127811
Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M; JAPAN-ACS Investigators. Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J Am Coll Cardiol. 2009 Jul 21;54(4):293-302. doi: 10.1016/j.jacc.2009.04.033.
PubMed 19608026
Fukushima Y, Daida H, Morimoto T, Kasai T, Miyauchi K, Yamagishi S, Takeuchi M, Hiro T, Kimura T, Nakagawa Y, Yamagishi M, Ozaki Y, Matsuzaki M; JAPAN-ACS Investigators. Relationship between advanced glycation end products and plaque progression in patients with acute coronary syndrome: the JAPAN-ACS sub-study. Cardiovasc Diabetol. 2013 Jan 7;12:5. doi: 10.1186/1475-2840-12-5.
PubMed 23289728
Takashima H, Ozaki Y, Morimoto T, Kimura T, Hiro T, Miyauchi K, Nakagawa Y, Yamagishi M, Daida H, Mizuno T, Asai K, Kuroda Y, Kosaka T, Kuhara Y, Kurita A, Maeda K, Amano T, Matsuzaki M; JAPAN-ACS Investigators. Clustering of metabolic syndrome components attenuates coronary plaque regression during intensive statin therapy in patients with acute coronary syndrome: the JAPAN-ACS subanalysis study. Circ J. 2012;76(12):2840-7. doi: 10.1253/circj.cj-11-1495. Epub 2012 Sep 7.
PubMed 22972364
Ohashi T, Shibata R, Morimoto T, Kanashiro M, Ishii H, Ichimiya S, Hiro T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura T, Daida H, Murohara T, Matsuzaki M. Correlation between circulating adiponectin levels and coronary plaque regression during aggressive lipid-lowering therapy in patients with acute coronary syndrome: subgroup analysis of JAPAN-ACS study. Atherosclerosis. 2010 Sep;212(1):237-42. doi: 10.1016/j.atherosclerosis.2010.05.005. Epub 2010 May 11.
PubMed 20684825
Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M; JAPAN-ACS Investigators. Diabetes mellitus is a major negative determinant of coronary plaque regression during statin therapy in patients with acute coronary syndrome--serial intravascular ultrasound observations from the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome Trial (the JAPAN-ACS Trial). Circ J. 2010 Jun;74(6):1165-74. doi: 10.1253/circj.cj-09-0766. Epub 2010 May 12.
PubMed 20467151

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

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

All Coronary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
ClinicalTrials.gov ID: NCT00242944
Acronym / sponsor ID: H17-49
Conditions: Coronary Disease, Hypercholesterolemia
Keywords: Acute coronary syndrome, Hypercholesterolemia, Primary coronary intervention, Hydroxymethylglutaryl-CoA reductase inhibitors, coronary plaque, Angioplasty, Transluminal, Percutaneous Coronary, Ultrasonography, Interventional
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: Kyoto UniversityUniversity, hospital or other
Collaborators: Yamaguchi University Hospital, Juntendo University
Study start: Nov 2005
Primary completion: Oct 2007 (actual)
Study completion: Mar 2008 (actual)
First posted: 21 Oct 2005 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: PitavastatinPitavastatin
2	Active comparator	Drug: AtorvastatinAtorvastatin

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial
Patients 20 years or older at the time of their consent
Patients with hypercholesterolemia as defined by any of the following criteria:
Patients who have been diagnosed with acute coronary syndrome
Patients with successful percutaneous coronary intervention (PCI) by intravascular ultrasound (IVUS) guidance

Key exclusion criteria (12 listed)

Patients with bypass graft or in-stent restenosis at the site of PCI
Patients who had received PCI on the lesion in the past where the evaluation of coronary plaque volume is planned
Patients who had plaques in a non-culprit site and might receive PCI during the treatment period
Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors)
Patients with familial hypercholesterolemia

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
PitavastatinPitavastatin 4mg per day	Drug	1
AtorvastatinAtorvastatin 20mg per day	Drug	2

Primary outcome

plaque volume
Time frame: one year

24 secondary outcomes

total cholesterol (TC)
Time frame: one year
low-density lipoprotein (LDL)-cholesterol (LDL-C)
Time frame: one year
high-density lipoprotein (HDL)-cholesterol (HDL-C)
Time frame: one year
HDL2-C
Time frame: one year
HDL3-C
Time frame: one year
remnant like particles-cholesterol (RLP-C)
Time frame: one year
small dense LDL-C
Time frame: one year
non-HDL-C
Time frame: one year
LDL-C/HDL-C
Time frame: one year
apolipoprotein AI (apoA-I)
Time frame: one year
apoB
Time frame: one year
apoE
Time frame: one year
apoB/apoA-I
Time frame: one year
malondialdehyde-modified LDL (MDA-LDL)
Time frame: one year
phospholipids
Time frame: one year
lipoprotein(a) [Lp(a)]
Time frame: one year
high-sensitivity C-reactive protein (hs-CRP)
Time frame: one year
pentraxin 3
Time frame: one year
leukocytes
Time frame: one year
coronary plaque area at culprit region
Time frame: one year
minimal lumen diameter (MLD) and percent (%) stenosis
Time frame: one year
major adverse cardiac events (cardiac death, Q or non-Q myocardial infarction and target vessel revascularization)
Time frame: one year
number of deaths from any cause
Time frame: one year
frequency of adverse drug reactions
Time frame: one year

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 4 Oct 2023.
Background: PubMed 17127811Miyauchi K, Kimura T, Morimoto T, Nakagawa Y, Yamagishi M, Ozaki Y, Hiro T, Daida H, Matsuzaki M. Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome (JAPAN-ACS): rationale and design. Circ J. 2006 Dec;70(12):1624-8. doi: 10.1253/circj.70.1624.
Results publication: PubMed 19608026Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M; JAPAN-ACS Investigators. Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J Am Coll Cardiol. 2009 Jul 21;54(4):293-302. doi: 10.1016/j.jacc.2009.04.033.
Derived from this study: PubMed 23289728Fukushima Y, Daida H, Morimoto T, Kasai T, Miyauchi K, Yamagishi S, Takeuchi M, Hiro T, Kimura T, Nakagawa Y, Yamagishi M, Ozaki Y, Matsuzaki M; JAPAN-ACS Investigators. Relationship between advanced glycation end products and plaque progression in patients with acute coronary syndrome: the JAPAN-ACS sub-study. Cardiovasc Diabetol. 2013 Jan 7;12:5. doi: 10.1186/1475-2840-12-5.
Derived from this study: PubMed 22972364Takashima H, Ozaki Y, Morimoto T, Kimura T, Hiro T, Miyauchi K, Nakagawa Y, Yamagishi M, Daida H, Mizuno T, Asai K, Kuroda Y, Kosaka T, Kuhara Y, Kurita A, Maeda K, Amano T, Matsuzaki M; JAPAN-ACS Investigators. Clustering of metabolic syndrome components attenuates coronary plaque regression during intensive statin therapy in patients with acute coronary syndrome: the JAPAN-ACS subanalysis study. Circ J. 2012;76(12):2840-7. doi: 10.1253/circj.cj-11-1495. Epub 2012 Sep 7.
Derived from this study: PubMed 20684825Ohashi T, Shibata R, Morimoto T, Kanashiro M, Ishii H, Ichimiya S, Hiro T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura T, Daida H, Murohara T, Matsuzaki M. Correlation between circulating adiponectin levels and coronary plaque regression during aggressive lipid-lowering therapy in patients with acute coronary syndrome: subgroup analysis of JAPAN-ACS study. Atherosclerosis. 2010 Sep;212(1):237-42. doi: 10.1016/j.atherosclerosis.2010.05.005. Epub 2010 May 11.
Derived from this study: PubMed 20467151Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M; JAPAN-ACS Investigators. Diabetes mellitus is a major negative determinant of coronary plaque regression during statin therapy in patients with acute coronary syndrome--serial intravascular ultrasound observations from the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome Trial (the JAPAN-ACS Trial). Circ J. 2010 Jun;74(6):1165-74. doi: 10.1253/circj.cj-09-0766. Epub 2010 May 12.

Related trials for Coronary Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

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.

Masunori Matsuzaki, MD, PhD study chair

Professor of Medicine, Department of Cardiovascular Medicine, Yamaguchi University Graduate School of Medicine

Hiroyuki Daida, MD principal investigator

Professor of Medicine, Department of Cardiovascular Medicine, Juntendo University School of Medicine

Takeshi Kimura, MD principal investigator

Associate Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pitavastatin and Atorvastatin in people with Coronary Disease and Hypercholesterolemia, run by Kyoto University at 3 sites in Japan.

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 9 inclusion and 12 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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?

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?

plaque volume (time frame: one year). 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 NCT00242944, which also lists 6 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 4 Oct 2023.