Platelet Aggregation InhibitorsPhase 4NCT00799396
Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
A Phase 4 study testing Clopidogrel and Aspirin in people with Platelet Aggregation Inhibitors and Coronary Heart Disease, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in treatment response may be linked to genetics. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation Inhibitors, Coronary Heart Disease
- What is being tested?
- Clopidogrel and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2012
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Of Old Order Amish descent
Who cannot join
- Currently pregnant or less than 6 months have passed since delivery
- Has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
- Has severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it unethical not to recommend prompt treatment
- Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
- Is taking vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
- Has a coexisting malignancy
Show all 14Show fewer
- Has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 mIU/L
- Has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
- Is currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
- Has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
- Has thrombocytopenia, defined by a platelet count less than 75,000
- Has had surgery within the last 6 months
- Has an aspirin or clopidogrel allergy
- Currently breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Amish Research Clinic
Lancaster, Pennsylvania, 17601
About this study
Official title: Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study)
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in treatment response may be linked to genetics. This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses.
Read the detailed description
CHD is the leading cause of death in the United States. Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events. Two of the most common anti-platelet agents are aspirin and clopidogrel. However, up to 25% to 30% of people do not respond to these medications. Evidence indicates that treatment response may be related to genetics. The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy.
This study is part of a larger group of studies called the Pharmacogenomics Research Network (PGRN). Participants will include the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population. Participants will receive 300 mg of clopidogrel on the first day, then 75 mg of clopidogrel per day for the next 6 days. On the last day of clopidogrel treatment, participants will take a single dose of 324 mg aspirin. Participants will undergo platelet function tests before and after clopidogrel alone, and then again after taking clopidogrel plus aspirin. Using the gene variation profiles across the genome, researchers will analyze which genes correspond to treatment response.
- Being tested
- Clopidogrel, Aspirin
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
300 mg on first day, then 75 mg per day for the next 6 days
AspirinDrug
Single dose of 324 mg on the last day of clopidogrel treatment
| Study group | Role | What they receive |
|---|---|---|
| Overall Study | Experimental | Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. Receives: Drug: Clopidogrel; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Platelet Function in Response to Clopidogrel
Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.
Measured: Measured at baseline, and after clopidogrel treatment
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin
Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation
Measured: Measured at baseline, and after clopidogrel plus aspirin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startJul 2006
- Primary completionFeb 2012
- Study completionFeb 2012
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 (8)Papers the sponsor has linked to this study.
- Other trials for Platelet Aggregation InhibitorsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alan Shuldiner, University of Maryland, Baltimore
- Investigators
- Alan R. Shuldiner, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799396
- Sponsor's protocol ID
- HP-00043419
- Other IDs
- U01 HL074518-01, U01GM074518
- Status last verified
- Feb 2022
- First submitted
- 26 Nov 2008
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
PubMed 19706858Bozzi LM, Mitchell BD, Lewis JP, Ryan KA, Herzog WR, O'Connell JR, Horenstein RB, Shuldiner AR, Yerges-Armstrong LM. The Pharmacogenomics of Anti-Platelet Intervention (PAPI) Study: Variation in Platelet Response to Clopidogrel and Aspirin. Curr Vasc Pharmacol. 2016;14(1):116-24. doi: 10.2174/1570161113666150916094829.
PubMed 26374108Lewis JP, Ryan K, O'Connell JR, Horenstein RB, Damcott CM, Gibson Q, Pollin TI, Mitchell BD, Beitelshees AL, Pakzy R, Tanner K, Parsa A, Tantry US, Bliden KP, Post WS, Faraday N, Herzog W, Gong Y, Pepine CJ, Johnson JA, Gurbel PA, Shuldiner AR. Genetic variation in PEAR1 is associated with platelet aggregation and cardiovascular outcomes. Circ Cardiovasc Genet. 2013 Apr;6(2):184-92. doi: 10.1161/CIRCGENETICS.111.964627. Epub 2013 Feb 7.
PubMed 23392654Lewis JP, Horenstein RB, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Tanner K, Chai S, Bliden KP, Tantry US, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Gurbel PA, Shuldiner AR. The functional G143E variant of carboxylesterase 1 is associated with increased clopidogrel active metabolite levels and greater clopidogrel response. Pharmacogenet Genomics. 2013 Jan;23(1):1-8. doi: 10.1097/FPC.0b013e32835aa8a2.
PubMed 23111421Lewis JP, Fisch AS, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Shen H, Tanner K, Horenstein RB, Pakzy R, Tantry US, Bliden KP, Gurbel PA, Shuldiner AR. Paraoxonase 1 (PON1) gene variants are not associated with clopidogrel response. Clin Pharmacol Ther. 2011 Oct;90(4):568-74. doi: 10.1038/clpt.2011.194. Epub 2011 Aug 31.
PubMed 21881565Lewis JP, Stephens SH, Horenstein RB, O'Connell JR, Ryan K, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Mitchell BD, Shuldiner AR. The CYP2C19*17 variant is not independently associated with clopidogrel response. J Thromb Haemost. 2013 Sep;11(9):1640-6. doi: 10.1111/jth.12342.
PubMed 23809542Bergmeijer TO, Reny JL, Pakyz RE, Gong L, Lewis JP, Kim EY, Aradi D, Fernandez-Cadenas I, Horenstein RB, Lee MTM, Whaley RM, Montaner J, Gensini GF, Cleator JH, Chang K, Holmvang L, Hochholzer W, Roden DM, Winter S, Altman RB, Alexopoulos D, Kim HS, Dery JP, Gawaz M, Bliden K, Valgimigli M, Marcucci R, Campo G, Schaeffeler E, Dridi NP, Wen MS, Shin JG, Simon T, Fontana P, Giusti B, Geisler T, Kubo M, Trenk D, Siller-Matula JM, Ten Berg JM, Gurbel PA, Hulot JS, Mitchell BD, Schwab M, Ritchie MD, Klein TE, Shuldiner AR; ICPC Investigators. Genome-wide and candidate gene approaches of clopidogrel efficacy using pharmacodynamic and clinical end points-Rationale and design of the International Clopidogrel Pharmacogenomics Consortium (ICPC). Am Heart J. 2018 Apr;198:152-159. doi: 10.1016/j.ahj.2017.12.010. Epub 2017 Dec 17.
PubMed 29653637Salimi S, Lewis JP, Yerges-Armstrong LM, Mitchell BD, Saeed F, O'Connell JR, Perry JA, Ryan KA, Shuldiner AR, Parsa A. Clopidogrel Improves Skin Microcirculatory Endothelial Function in Persons With Heightened Platelet Aggregation. J Am Heart Assoc. 2016 Oct 31;5(11):e003751. doi: 10.1161/JAHA.116.003751.
PubMed 27799230
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study)
- ClinicalTrials.gov ID
- NCT00799396
- Acronym / sponsor ID
- HP-00043419
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in treatment response may be linked to genetics. This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses.
Detailed description
CHD is the leading cause of death in the United States. Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events. Two of the most common anti-platelet agents are aspirin and clopidogrel. However, up to 25% to 30% of people do not respond to these medications. Evidence indicates that treatment response may be related to genetics. The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy.
This study is part of a larger group of studies called the Pharmacogenomics Research Network (PGRN). Participants will include the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population. Participants will receive 300 mg of clopidogrel on the first day, then 75 mg of clopidogrel per day for the next 6 days. On the last day of clopidogrel treatment, participants will take a single dose of 324 mg aspirin. Participants will undergo platelet function tests before and after clopidogrel alone, and then again after taking clopidogrel plus aspirin. Using the gene variation profiles across the genome, researchers will analyze which genes correspond to treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Study | Experimental | Drug: Clopidogrel, Drug: AspirinParticipants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Of Old Order Amish descent
Key exclusion criteria (14 listed)
- Currently pregnant or less than 6 months have passed since delivery
- Has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
- Has severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it unethical not to recommend prompt treatment
- Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
- Is taking vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
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 |
|---|---|---|
| Clopidogrel300 mg on first day, then 75 mg per day for the next 6 days | Drug | Overall Study |
| AspirinSingle dose of 324 mg on the last day of clopidogrel treatment | Drug | Overall Study |
Primary outcome
Changes in Platelet Function in Response to Clopidogrel
Time frame: Measured at baseline, and after clopidogrel treatment
Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin
Time frame: Measured at baseline, and after clopidogrel plus aspirin treatment
Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19706858Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
- Results publication: PubMed 26374108Bozzi LM, Mitchell BD, Lewis JP, Ryan KA, Herzog WR, O'Connell JR, Horenstein RB, Shuldiner AR, Yerges-Armstrong LM. The Pharmacogenomics of Anti-Platelet Intervention (PAPI) Study: Variation in Platelet Response to Clopidogrel and Aspirin. Curr Vasc Pharmacol. 2016;14(1):116-24. doi: 10.2174/1570161113666150916094829.
- Results publication: PubMed 23392654Lewis JP, Ryan K, O'Connell JR, Horenstein RB, Damcott CM, Gibson Q, Pollin TI, Mitchell BD, Beitelshees AL, Pakzy R, Tanner K, Parsa A, Tantry US, Bliden KP, Post WS, Faraday N, Herzog W, Gong Y, Pepine CJ, Johnson JA, Gurbel PA, Shuldiner AR. Genetic variation in PEAR1 is associated with platelet aggregation and cardiovascular outcomes. Circ Cardiovasc Genet. 2013 Apr;6(2):184-92. doi: 10.1161/CIRCGENETICS.111.964627. Epub 2013 Feb 7.
- Results publication: PubMed 23111421Lewis JP, Horenstein RB, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Tanner K, Chai S, Bliden KP, Tantry US, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Gurbel PA, Shuldiner AR. The functional G143E variant of carboxylesterase 1 is associated with increased clopidogrel active metabolite levels and greater clopidogrel response. Pharmacogenet Genomics. 2013 Jan;23(1):1-8. doi: 10.1097/FPC.0b013e32835aa8a2.
- Results publication: PubMed 21881565Lewis JP, Fisch AS, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Shen H, Tanner K, Horenstein RB, Pakzy R, Tantry US, Bliden KP, Gurbel PA, Shuldiner AR. Paraoxonase 1 (PON1) gene variants are not associated with clopidogrel response. Clin Pharmacol Ther. 2011 Oct;90(4):568-74. doi: 10.1038/clpt.2011.194. Epub 2011 Aug 31.
- Results publication: PubMed 23809542Lewis JP, Stephens SH, Horenstein RB, O'Connell JR, Ryan K, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Mitchell BD, Shuldiner AR. The CYP2C19*17 variant is not independently associated with clopidogrel response. J Thromb Haemost. 2013 Sep;11(9):1640-6. doi: 10.1111/jth.12342.
- Derived from this study: PubMed 29653637Bergmeijer TO, Reny JL, Pakyz RE, Gong L, Lewis JP, Kim EY, Aradi D, Fernandez-Cadenas I, Horenstein RB, Lee MTM, Whaley RM, Montaner J, Gensini GF, Cleator JH, Chang K, Holmvang L, Hochholzer W, Roden DM, Winter S, Altman RB, Alexopoulos D, Kim HS, Dery JP, Gawaz M, Bliden K, Valgimigli M, Marcucci R, Campo G, Schaeffeler E, Dridi NP, Wen MS, Shin JG, Simon T, Fontana P, Giusti B, Geisler T, Kubo M, Trenk D, Siller-Matula JM, Ten Berg JM, Gurbel PA, Hulot JS, Mitchell BD, Schwab M, Ritchie MD, Klein TE, Shuldiner AR; ICPC Investigators. Genome-wide and candidate gene approaches of clopidogrel efficacy using pharmacodynamic and clinical end points-Rationale and design of the International Clopidogrel Pharmacogenomics Consortium (ICPC). Am Heart J. 2018 Apr;198:152-159. doi: 10.1016/j.ahj.2017.12.010. Epub 2017 Dec 17.
- Derived from this study: PubMed 27799230Salimi S, Lewis JP, Yerges-Armstrong LM, Mitchell BD, Saeed F, O'Connell JR, Perry JA, Ryan KA, Shuldiner AR, Parsa A. Clopidogrel Improves Skin Microcirculatory Endothelial Function in Persons With Heightened Platelet Aggregation. J Am Heart Assoc. 2016 Oct 31;5(11):e003751. doi: 10.1161/JAHA.116.003751.
- dbGaP submission for the PAPI studyLink provided by the sponsor.
Related trials for Platelet Aggregation Inhibitors
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Active, not recruitingPhase 4
Effect of Two Weeks of Low-Dose Apixaban on Platelet Reactivity in Patients With Stable Coronary Artery Disease on Dual Antiplatelet Therapy (Aspirin and Clopidogrel)
Coronary Artery Disease, High On-treatment Platelet Reactivity (HTPR)
Not yet recruitingObservational study
Regulation of Platelet Function in Older Patients With Atrial Fibrillation
Atrial Fibrillation, Thrombotic Risk
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.
Alan R. Shuldiner, MD principal investigator
University of Maryland, Baltimore
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 and Aspirin in people with Platelet Aggregation Inhibitors and Coronary Heart Disease, run by University of Maryland, Baltimore 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 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. 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 28 Mar 2016). 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?
Changes in Platelet Function in Response to Clopidogrel (time frame: Measured at baseline, and after clopidogrel treatment). 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 NCT00799396, which also lists 8 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 24 Feb 2022.