Unstable Angina or Non ST Elevated Myocardial InfarctionPhase 4DUBIUSNCT02618837

Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers

A Phase 4 study testing Downstream strategy and Upstream strategy in people with Unstable Angina or Non ST Elevated Myocardial Infarction, run by University of Padova at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the impact on outcomes of the currently accepted antithrombotic strategies based on the administration of newer P2Y12 receptor blockers (prasugrel and ticagrelor) in a population of non ST elevated ACS (NSTEACS) patients with an initial invasive indication. Read more about this study

Who is it for?: Ages 18 to 84 years
Conditions the study is for: Unstable Angina or Non ST Elevated Myocardial Infarction
What is being tested?: Downstream strategy and Upstream strategy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,520 participants
Where: 1 siteItaly
Study dates: 14 Dec 2015to Aug 2022
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 18 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 and < 85
Non ST elevated acute coronary syndrome (unstable angina, non ST elevated myocardial infarction), with an onset of symptoms during the previous 24 hours.
An initial invasive strategy is chosen (the patient is expected to undergo coronary angiography within 72 h from admission).
Subject is able to start therapy with a new P2Y12 inhibitor (prasugrel or ticagrelor) OR is on a maintenance dose of clopidogrel or ticlopidine and is able to switch to a new P2Y12 inhibitor (prasugrel or ticagrelor).
Subject is able to verbally confirm understanding of risks and benefits of dual antiplatelet therapy in coronary acute syndromes and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Patient agrees to comply with follow-up evaluations.

Who cannot join

Known hypersensitivity/contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, heparin or bivalirudin, or sensitivity to contrast media, which can't be adequately pre-medicated.
Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure.
Shock.
Have severe hepatic impairment defined as Child Pugh Class C.
Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following screening. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to enrollment).
Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.

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Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
Currently participating in investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with current trial endpoints. Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure, including clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
Prior history of hemorrhagic or ischemic stroke, a transient ischemic attack (TIA), or sub-arachnoid hemorrhage.
History of intracranial neoplasm, arterovenous malformation, or aneurysm.
Have received fibrinolytic therapy within 48 hours of entry or randomization into the study.
Have active pathological bleeding or history of bleeding diathesis.
Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
Have had recent surgery (within 4 weeks of entry into the study) or are scheduled to undergo surgery within the next 2 months.
Have received a loading dose of a thienopyridine (ticlopidine, clopidogrel or prasugrel) or a maintenance dose of prasugrel or Ticlopidine or Ticagrelor within 7 days of entry into the study.
Are receiving a GPIIb/IIIa inhibitor (eptifibatide, tirofiban, or abciximab).
Are receiving warfarin or other coumarin derivatives.
Are receiving or will receive oral anticoagulation or other oral antiplatelet therapy (except aspirin [ASA]) that cannot be safely discontinued within the next 3 months.
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require >2 weeks of daily treatment with NSAID or COX2 inhibitors during the study.
Concomitant therapy with a strong cytochrome P-4503A inhibitor or inducer.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Ospedaliera di Padova
Padova, Veneto, 35131

Other trials in Italy

About this study

Official title: Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non ST Elevated acUte Coronary Syndromes With Initial Invasive Indication

Furthermore, to evaluate the effects of bivalirudin administration in comparison to standard therapy with unfractioned heparin (plus provisional anti-GPIIbIIIa) in NSTEACSpatients who undergo PCI and will thus receive these potent antiplatelet agents which may theoretically favor the occurrence of bleedings.

A combined measure of efficacy and safety endpoints, the so-called net clinical benefit (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.

Conditions: Unstable Angina or Non ST Elevated Myocardial Infarction
Being tested: Downstream strategy, Upstream strategy
Keywords: NSTEMI, NSTEACS, prasugrel, ticagrelor, Downstream versus Upstream strategy
Medical subject headings: Angina, Unstable, Non-ST Elevated Myocardial Infarction

What participants receive

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

Downstream strategyProcedure or surgery
At diagnosis:
Subjects receive a loading dose of aspirin (150-300mg). Administration of clopidogrel is allowed only for patients already receiving clopidogrel
Pre-procedure:
Until PCI is performed, all subjects will be maintained at a minimum of 75mg of aspirin (Subjects with clopidogrel may be maintained at a minimum of 75mg of clopidogrel)
Peri- and post-procedure:
For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; choice based upon clinical judgement.
In this case, subject will be randomized in a 1:1 fashion to prasugrel vs ticagrelor
At the time of PCI, the loading doses required (according to randomization):
- Ticagrelor 180mg, maintained at 90mg b.i.d. for at least 12 months
- Prasugrel 60mg, maintained at a minimum of 75mg of aspirin for at least 12 months plus 10mg of prasugrel* daily for at least 12 months
- If subject is >75 years old or <60 kg, daily dose of prasugrel should be 5mg
Upstream strategyProcedure or surgery
At the time of diagnosis:
Subjects randomized in this arm must receive a loading dose of aspirin (150-300 mg) and ticagrelor (180 mg) at admission as soon as possible.
Pre-procedure:
All subjects will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, until coronary angiography is performed.
Peri- and post-procedure:
For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; the choice of the anticoagulant at the time of PCI will be based upon clinical judgement.
All subjects randomized to the upstream strategy arm will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, for at least 12 months. If the subject develops hypersensitivity or intolerance to ticagrelor, clopidogrel may be used as a substitute at a dose in accordance with standard hospital practice (to be documented in the eCRF).

Study groups in NCT02618837
Study group	Role	What they receive
Downstream strategy arm	Active comparator	downstream administration strategy of P2Y12 receptor blockers (prasugrel or ticagrelor) Receives: Procedure: Downstream strategy
Upstream strategy arm	Active comparator	upstream administration strategy (ticagrelor only) Receives: Procedure: Upstream strategy

What is being measured

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

Incidence of NACE (Net Adverse Cardiac Events) at 30 days
NACE (Net Adverse Cardiac Events) defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding.
Measured: 30 days
Incidence of NACE (Net Adverse Cardiac Events) at 12 months
NACE (Net Adverse Cardiac Events) defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding.
Measured: 12 months

Secondary outcomes (10)

Incidence of single digit and composite of death from vascular causes, MI, stroke, TIA, severe recurrent ischemia, recurrent ischemia, or other arterial thrombotic event.
Measured: 30 days, 12 months
Incidence of death from any cause
Measured: 30 days, 12 months
Incidence of any stent thrombosis according to the ARC criteria
Measured: 30 days, 12 months
Incidence of target vessel revascularization (TVR).
Measured: 30 days, 12 months
Incidence of NACE (Net Adverse Cardiac Events) occurred in the period between admission and coronary revascularization
NACE (Net Adverse Cardiac Events) occurred in the period between admission and coronary revascularization defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 2, 3, 4 and 5 bleeding,
Measured: 30 days, 12 months
Incidence of target lesion revascularization (TLR)
Measured: 30 days, 12 months
Incidence of compliance to mandated antiplatelet therapy
Measured: 30 days, 12 months
Incidence of BARC type 2, 3, 4 and 5 bleeding (single digit and composite).
Measured: 30 days, 12 months
Incidence of all TIMI major, major-life-threatening, and minor bleeding
Measured: 30 days, 12 months
Incidence of all CABG surgery-related TIMI major, minor, and composite of TIMI major or minor bleeding
Measured: 30 days, 12 months

Timeline

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

14 Dec 2015Aug 2022

First posted1 Dec 2015 (estimated)
Study start14 Dec 2015
Primary completionJun 2021 (estimated)
Study completionAug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Unstable Angina or Non ST Elevated 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,520 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02618837
Sponsor's protocol ID: DUBIUS - 0015746
Acronym: DUBIUS
Status last verified: Dec 2020
First submitted: 29 Oct 2015
Last updated: 2 Dec 2020
Results posted: No

Publications

Tarantini G, Mojoli M, Varbella F, Caporale R, Rigattieri S, Ando G, Cirillo P, Pierini S, Santarelli A, Sganzerla P, De Cesare N, Limbruno U, Lupi A, Ricci R, Cernetti C, Favero L, Saia F, Roncon L, Gasparetto V, Ferlini M, Ronco F, Ferri L, Trabattoni D, Russo A, Guiducci V, Penzo C, Tarantino F, Mauro C, Marchese A, Castiglioni B, La Manna A, Martinato M, Gregori D, Angiolillo DJ, Musumeci G. Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial. Trials. 2020 Nov 24;21(1):966. doi: 10.1186/s13063-020-04859-1.
PubMed 33234137
Tarantini G, Mojoli M, Varbella F, Caporale R, Rigattieri S, Ando G, Cirillo P, Pierini S, Santarelli A, Sganzerla P, Cacciavillani L, Babuin L, De Cesare N, Limbruno U, Massoni A, Rognoni A, Pavan D, Belloni F, Cernetti C, Favero L, Saia F, Fovino LN, Masiero G, Roncon L, Gasparetto V, Ferlini M, Ronco F, Rossini R, Canova P, Trabattoni D, Russo A, Guiducci V, Penzo C, Tarantino F, Mauro C, Corrada E, Esposito G, Marchese A, Berti S, Martinato M, Azzolina D, Gregori D, Angiolillo DJ, Musumeci G; DUBIUS Investigators; Italian Society of Interventional Cardiology. Timing of Oral P2Y12 Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Nov 24;76(21):2450-2459. doi: 10.1016/j.jacc.2020.08.053. Epub 2020 Aug 31.
PubMed 32882390

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non ST Elevated acUte Coronary Syndromes With Initial Invasive Indication
ClinicalTrials.gov ID: NCT02618837
Acronym / sponsor ID: DUBIUS / DUBIUS - 0015746
Conditions: Unstable Angina or Non ST Elevated Myocardial Infarction
Keywords: NSTEMI, NSTEACS, prasugrel, ticagrelor, Downstream versus Upstream strategy
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 2,520 participants (estimated)
Lead sponsor: University of PadovaUniversity, hospital or other
Collaborators: Azienda Ospedaliera di Padova
Study start: 14 Dec 2015 (actual)
Primary completion: Jun 2021 (estimated)
Study completion: Aug 2022 (estimated)
First posted: 1 Dec 2015 (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.

A combined measure of efficacy and safety endpoints, the so-called net clinical benefit (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Downstream strategy arm	Active comparator	Procedure: Downstream strategydownstream administration strategy of P2Y12 receptor blockers (prasugrel or ticagrelor)
Upstream strategy arm	Active comparator	Procedure: Upstream strategyupstream administration strategy (ticagrelor only)

Who may qualify

Ages: 18 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥ 18 and < 85
Non ST elevated acute coronary syndrome (unstable angina, non ST elevated myocardial infarction), with an onset of symptoms during the previous 24 hours.
An initial invasive strategy is chosen (the patient is expected to undergo coronary angiography within 72 h from admission).
Subject is able to start therapy with a new P2Y12 inhibitor (prasugrel or ticagrelor) OR is on a maintenance dose of clopidogrel or ticlopidine and is able to switch to a new P2Y12 inhibitor (prasugrel or ticagrelor).
Subject is able to verbally confirm understanding of risks and benefits of dual antiplatelet therapy in coronary acute syndromes and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Key exclusion criteria (20 listed)

Known hypersensitivity/contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, heparin or bivalirudin, or sensitivity to contrast media, which can't be adequately pre-medicated.
Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure.
Shock.
Have severe hepatic impairment defined as Child Pugh Class C.
Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following screening. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to enrollment).

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
Downstream strategyAt diagnosis: Subjects receive a loading dose of aspirin (150-300mg). Administration of clopidogrel is allowed only for patients already receiving clopidogrel Pre-procedure: Until PCI is performed, all subjects will be maintained at a minimum of 75mg of aspirin (Subjects with clopidogrel may be maintained at a minimum of 75mg of clopidogrel) Peri- and post-procedure: For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; choice based upon clinical judgement. In this case, subject will be randomized in a 1:1 fashion to prasugrel vs ticagrelor At the time of PCI, the loading doses required (according to randomization): * Ticagrelor 180mg, maintained at 90mg b.i.d. for at least 12 months * Prasugrel 60mg, maintained at a minimum of 75mg of aspirin for at least 12 months plus 10mg of prasugrel* daily for at least 12 months * If subject is >75 years old or <60 kg, daily dose of prasugrel should be 5mg	Procedure or surgery	Downstream strategy arm
Upstream strategyAt the time of diagnosis: Subjects randomized in this arm must receive a loading dose of aspirin (150-300 mg) and ticagrelor (180 mg) at admission as soon as possible. Pre-procedure: All subjects will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, until coronary angiography is performed. Peri- and post-procedure: For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; the choice of the anticoagulant at the time of PCI will be based upon clinical judgement. All subjects randomized to the upstream strategy arm will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, for at least 12 months. If the subject develops hypersensitivity or intolerance to ticagrelor, clopidogrel may be used as a substitute at a dose in accordance with standard hospital practice (to be documented in the eCRF).	Procedure or surgery	Upstream strategy arm

Primary outcome

Incidence of NACE (Net Adverse Cardiac Events) at 30 days
Time frame: 30 days
NACE (Net Adverse Cardiac Events) defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding.
Incidence of NACE (Net Adverse Cardiac Events) at 12 months
Time frame: 12 months
NACE (Net Adverse Cardiac Events) defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding.

10 secondary outcomes

Incidence of single digit and composite of death from vascular causes, MI, stroke, TIA, severe recurrent ischemia, recurrent ischemia, or other arterial thrombotic event.
Time frame: 30 days, 12 months
Incidence of death from any cause
Time frame: 30 days, 12 months
Incidence of any stent thrombosis according to the ARC criteria
Time frame: 30 days, 12 months
Incidence of target vessel revascularization (TVR).
Time frame: 30 days, 12 months
Incidence of NACE (Net Adverse Cardiac Events) occurred in the period between admission and coronary revascularization
Time frame: 30 days, 12 months
Incidence of target lesion revascularization (TLR)
Time frame: 30 days, 12 months
Incidence of compliance to mandated antiplatelet therapy
Time frame: 30 days, 12 months
Incidence of BARC type 2, 3, 4 and 5 bleeding (single digit and composite).
Time frame: 30 days, 12 months
Incidence of all TIMI major, major-life-threatening, and minor bleeding
Time frame: 30 days, 12 months
Incidence of all CABG surgery-related TIMI major, minor, and composite of TIMI major or minor bleeding
Time frame: 30 days, 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
Derived from this study: PubMed 33234137Tarantini G, Mojoli M, Varbella F, Caporale R, Rigattieri S, Ando G, Cirillo P, Pierini S, Santarelli A, Sganzerla P, De Cesare N, Limbruno U, Lupi A, Ricci R, Cernetti C, Favero L, Saia F, Roncon L, Gasparetto V, Ferlini M, Ronco F, Ferri L, Trabattoni D, Russo A, Guiducci V, Penzo C, Tarantino F, Mauro C, Marchese A, Castiglioni B, La Manna A, Martinato M, Gregori D, Angiolillo DJ, Musumeci G. Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial. Trials. 2020 Nov 24;21(1):966. doi: 10.1186/s13063-020-04859-1.
Derived from this study: PubMed 32882390Tarantini G, Mojoli M, Varbella F, Caporale R, Rigattieri S, Ando G, Cirillo P, Pierini S, Santarelli A, Sganzerla P, Cacciavillani L, Babuin L, De Cesare N, Limbruno U, Massoni A, Rognoni A, Pavan D, Belloni F, Cernetti C, Favero L, Saia F, Fovino LN, Masiero G, Roncon L, Gasparetto V, Ferlini M, Ronco F, Rossini R, Canova P, Trabattoni D, Russo A, Guiducci V, Penzo C, Tarantino F, Mauro C, Corrada E, Esposito G, Marchese A, Berti S, Martinato M, Azzolina D, Gregori D, Angiolillo DJ, Musumeci G; DUBIUS Investigators; Italian Society of Interventional Cardiology. Timing of Oral P2Y12 Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Nov 24;76(21):2450-2459. doi: 10.1016/j.jacc.2020.08.053. Epub 2020 Aug 31.

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Downstream strategy and Upstream strategy in people with Unstable Angina or Non ST Elevated Myocardial Infarction, run by University of Padova at 1 site in Italy.

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 20 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: status not confirmed, as of the sponsor's last update on 2 Dec 2020. 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 Italy. 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?

Results are not available in the source record.

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?

Incidence of NACE (Net Adverse Cardiac Events) at 30 days (time frame: 30 days). 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 NCT02618837, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.