Myocardial InfarctionPhase 4Dan-DAPTNCT05262803
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
A Phase 4 study testing CYP2C19*2/*3 and Shorter DAPT duration in people with Myocardial Infarction, run by Rikke Sorensen at 6 sites in Denmark.
Trial summary
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- CYP2C19*2/*3 and Shorter DAPT duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,808 participants
- Where
- 6 sitesDenmark
- Study dates
- 17 Jun 2022to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- MI caused by atherothrombotic CAD (Type 1 MI) according to "The Fourth Universal Definition of MI", which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value >99th percentile and at least one of the following criteria assessed by the treating physician:
- symptoms indicating acute myocardial ischemia
- new ischemic changes on the electrocardiogram
- development of pathological Q-waves
- imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
- visible coronary thrombus by angiography
- PRECISE-DAPT score ≥25
- Age ≥18 years
Who cannot join
- Contraindications including allergies to ASA or P2Y12 inhibitors
- Indication for oral anticoagulation
- Previous stent thrombosis
- Life expectancy <1 year
- Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
- Prior intracranial hemorrhage
Show all 10Show fewer
- Active bleeding (BARC ≥2) at randomization
- Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
- Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg)
- Unable to understand and follow study-related instructions or to comply with study protocol
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Phillip Freeman, BSc, MBBS, MRCP, Ph.D.
- Recruiting
The Heart Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Rikke Sorensen, MD, Ph.D., 35456851 ext. +45, rikke.soerensen@regionh.dk
Rikke Sorensen, MD, Ph.D.
- Recruiting
Herlev and Gentofte University Hospital - Gentofte
Hellerup, 2900
Mette G Charlot, MD, Ph.D.
- Recruiting
Odense University Hospital
Odense, 5000
Karsten T Veien, MD, DMSc
- Recruiting
Zealand University Hospital
Roskilde, 4000
Henning S Kelbaek, MD, DMSc
- Recruiting
Aarhus University Hospital
Skejby, 8200
Erik L Grove, Assoc.prof., MD, Ph.D.
Erik L Grove, Assoc. prof., MD, Ph.D
About this study
Official title: Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction Treated With Percutaneous Coronary Intervention - The Dan-DAPT Trial
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. These drugs have replaced the older drug, clopidogrel, as approximately 30% of patients are low-responders to clopidogrel for genetic reasons. However, the newer drugs introduce a significant risk of serious bleeding.
Aim: The aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely.
Read more
Hypothesis: Significantly reduced bleeding with a similar preventive effect are expected.
Design: The Dan-DAPT trial include high bleeding risk patients with heart attacks from Danish hospitals (Rigshospitalet, Aarhus, Odense, Aalborg, Roskilde, and Gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.
- Conditions
- Myocardial Infarction
- Being tested
- CYP2C19*2/*3, Shorter DAPT duration
- Keywords
- High bleeding risk, CYP2C19 genotyping, Dual antiplatelet therapy, Percutaneous coronary intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19*2/*3Genetic
- Non-carriers of CYP2C19*2/*3 loss-of-function alleles: DAPT with clopidogrel and ASA
- Carriers of CYP2C19*2/*3 loss-of-function alleles: DAPT with prasugrel (or ticagrelor) and ASA
Shorter DAPT durationOther
Duration of DAPT is shortened to 3 months
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care DAPT | No intervention | Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel or ticagrelor for 6 months followed by ASA monotherapy. |
| Genotype-guided DAPT | Experimental | DAPT according to CYP2C19*2/*3-genotyping for 6 months followed by ASA monotherapy. Receives: Genetic: CYP2C19*2/*3 |
| Shorter genotype-guided DAPT | Experimental | DAPT according to CYP2C19*2/*3-genotyping for 3 months followed by ASA monotherapy. Receives: Genetic: CYP2C19*2/*3; Other: Shorter DAPT duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
BARC type 2-5 bleedings
A composite of type 2-5 non-access site bleeding according to the Bleeding Academic Research Consortium (BARC) scale, ranging from bleedings that require diagnosis, hospitalization, or treatment by a health care professional (BARC type 2) to fatal bleedings (BARC type 5)
Measured: 1 year
NACE (Net adverse clinical events)
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleeding
Measured: 1 year
Secondary outcomes (8)
MACE (Major adverse cardiovascular events)
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis and ischemic stroke
Measured: 3, 6, and 12 months
Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions
Measured: 3, 6, and 12 months
All-cause mortality
Measured: 3, 6, and 12 months
Non-hemorrhagic cardiovascular death
Measured: 3, 6, and 12 months
Ischemic events
Recurrent MI, definite/probable stent thrombosis, any (non-)target vessel revascularization, coronary artery bypass grafting, ischemic stroke
Measured: 3, 6, and 12 months
Discontinuation or switch to another antiplatelet drug
Measured: 3, 6, and 12 months
Pharmacoeconomic endpoint including direct and in-direct medical costs
Direct medical costs (e.g. costs for genotyping, medicinal products, re-hospitalization) and indirect costs (e.g. absence from the workforce).
Measured: 3, 6, and 12 months
Self-reported quality of life scores
Self-reported quality of life scores according to the EQ-5D-5L questionaries in electronic form
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start17 Jun 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
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 Myocardial InfarctionStudies 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
- 2,808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rikke Sorensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rikke Sorensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262803
- Sponsor's protocol ID
- 2022-500125-32-00
- Acronym
- Dan-DAPT
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):34-78. doi: 10.1093/ejcts/ezx334. No abstract available.
PubMed 29045581Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
PubMed 32860058Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.
PubMed 28290994Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI. N Engl J Med. 2019 Oct 24;381(17):1621-1631. doi: 10.1056/NEJMoa1907096. Epub 2019 Sep 3.
PubMed 31479209Jacobsen MR, Engstrom T, Torp-Pedersen C, Gislason G, Glinge C, Butt JH, Fosbol EL, Holmvang L, Pedersen F, Kober L, Jabbari R, Sorensen R. Clopidogrel, prasugrel, and ticagrelor for all-comers with ST-segment elevation myocardial infarction. Int J Cardiol. 2021 Nov 1;342:15-22. doi: 10.1016/j.ijcard.2021.07.047. Epub 2021 Jul 24.
PubMed 34311012Jacobsen MR, Jabbari R, Grove EL, Maeng M, Veien K, Hougaard M, Freeman P, Kelbaek H, Charlot MG, Engstrom T, Sorensen R. Genotype-guided de-escalation and abbreviation of dual antiplatelet therapy in patients with myocardial infarction and high bleeding risk: Design and rationale of the investigator-initiated, multicenter, randomized, controlled trial, DAN-DAPT. Am Heart J. 2025 Jul;285:74-81. doi: 10.1016/j.ahj.2025.02.020. Epub 2025 Feb 26.
PubMed 40015616
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction Treated With Percutaneous Coronary Intervention - The Dan-DAPT Trial
- ClinicalTrials.gov ID
- NCT05262803
- Acronym / sponsor ID
- Dan-DAPT / 2022-500125-32-00
- Conditions
- Myocardial Infarction
- Keywords
- High bleeding risk, CYP2C19 genotyping, Dual antiplatelet therapy, Percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,808 participants (estimated)
- Lead sponsor
- Rikke SorensenUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. These drugs have replaced the older drug, clopidogrel, as approximately 30% of patients are low-responders to clopidogrel for genetic reasons. However, the newer drugs introduce a significant risk of serious bleeding.
Aim: The aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely.
Hypothesis: Significantly reduced bleeding with a similar preventive effect are expected.
Design: The Dan-DAPT trial include high bleeding risk patients with heart attacks from Danish hospitals (Rigshospitalet, Aarhus, Odense, Aalborg, Roskilde, and Gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care DAPT | No intervention | –Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel or ticagrelor for 6 months followed by ASA monotherapy. |
| Genotype-guided DAPT | Experimental | Genetic: CYP2C19*2/*3DAPT according to CYP2C19*2/*3-genotyping for 6 months followed by ASA monotherapy. |
| Shorter genotype-guided DAPT | Experimental | Genetic: CYP2C19*2/*3, Other: Shorter DAPT durationDAPT according to CYP2C19*2/*3-genotyping for 3 months followed by ASA monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- MI caused by atherothrombotic CAD (Type 1 MI) according to "The Fourth Universal Definition of MI", which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value >99th percentile and at least one of the following criteria assessed by the treating physician:
- PRECISE-DAPT score ≥25
- Age ≥18 years
Key exclusion criteria (10 listed)
- Contraindications including allergies to ASA or P2Y12 inhibitors
- Indication for oral anticoagulation
- Previous stent thrombosis
- Life expectancy <1 year
- Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation
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 |
|---|---|---|
| CYP2C19*2/*3* Non-carriers of CYP2C19*2/*3 loss-of-function alleles: DAPT with clopidogrel and ASA * Carriers of CYP2C19*2/*3 loss-of-function alleles: DAPT with prasugrel (or ticagrelor) and ASA | Genetic | Genotype-guided DAPT, Shorter genotype-guided DAPT |
| Shorter DAPT durationDuration of DAPT is shortened to 3 months | Other | Shorter genotype-guided DAPT |
Primary outcome
BARC type 2-5 bleedings
Time frame: 1 year
A composite of type 2-5 non-access site bleeding according to the Bleeding Academic Research Consortium (BARC) scale, ranging from bleedings that require diagnosis, hospitalization, or treatment by a health care professional (BARC type 2) to fatal bleedings (BARC type 5)
NACE (Net adverse clinical events)
Time frame: 1 year
A composite of all-cause mortality, recurrent myocardial infarction, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleeding
8 secondary outcomes
MACE (Major adverse cardiovascular events)
Time frame: 3, 6, and 12 months
Bleedings according to BARC and TIMI (Thrombolysis in Myocardial Infarction) defintions
Time frame: 3, 6, and 12 months
All-cause mortality
Time frame: 3, 6, and 12 months
Non-hemorrhagic cardiovascular death
Time frame: 3, 6, and 12 months
Ischemic events
Time frame: 3, 6, and 12 months
Discontinuation or switch to another antiplatelet drug
Time frame: 3, 6, and 12 months
Pharmacoeconomic endpoint including direct and in-direct medical costs
Time frame: 3, 6, and 12 months
Self-reported quality of life scores
Time frame: 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 29045581Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):34-78. doi: 10.1093/ejcts/ezx334. No abstract available.
- Background: PubMed 32860058Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
- Background: PubMed 28290994Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.
- Background: PubMed 31479209Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI. N Engl J Med. 2019 Oct 24;381(17):1621-1631. doi: 10.1056/NEJMoa1907096. Epub 2019 Sep 3.
- Background: PubMed 34311012Jacobsen MR, Engstrom T, Torp-Pedersen C, Gislason G, Glinge C, Butt JH, Fosbol EL, Holmvang L, Pedersen F, Kober L, Jabbari R, Sorensen R. Clopidogrel, prasugrel, and ticagrelor for all-comers with ST-segment elevation myocardial infarction. Int J Cardiol. 2021 Nov 1;342:15-22. doi: 10.1016/j.ijcard.2021.07.047. Epub 2021 Jul 24.
- Derived from this study: PubMed 40015616Jacobsen MR, Jabbari R, Grove EL, Maeng M, Veien K, Hougaard M, Freeman P, Kelbaek H, Charlot MG, Engstrom T, Sorensen R. Genotype-guided de-escalation and abbreviation of dual antiplatelet therapy in patients with myocardial infarction and high bleeding risk: Design and rationale of the investigator-initiated, multicenter, randomized, controlled trial, DAN-DAPT. Am Heart J. 2025 Jul;285:74-81. doi: 10.1016/j.ahj.2025.02.020. Epub 2025 Feb 26.
- Individual participant dataSharing planned: Undecided
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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.
6 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 CYP2C19*2/*3 and Shorter DAPT duration in people with Myocardial Infarction, run by Rikke Sorensen at 6 sites in Denmark.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikke Sorensen, MD, Ph.D. (35456851 ext. +45, rikke.soerensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BARC type 2-5 bleedings (time frame: 1 year). 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 NCT05262803, 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 15 Mar 2024.