StrokePhase 3RIISC-THETISNCT05476991
Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis
A Phase 3 study testing Colchicine 0.5 MG, Ticagrelor 90mg and Aspirin 75-300mg in people with Stroke and Stroke, Ischemic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Atherosclerosis
- What is being tested?
- Colchicine 0.5 MG, Ticagrelor 90mg and Aspirin 75-300mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2023to 1 Sep 2027
- Phase
- Phase 3
- 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
- Patient should have the following:
- Patient with:
- Cerebral infarction (CI) proven by neuro-imaging (MRI or head-CT), immediately once the neurologic deficit is stabilized (investigator judgement) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event (TIA with documented ischemic lesion (MRI or CT) in the appropriate area corresponding to the symptoms will be considered CI, following the current definition)
- Or TIA lasting more 10 minutes or more (with motor symptoms or aphasia/dysarthria or visual defect), with total resolution and no brain lesion on neuro-imaging (TIA) and with ipsilateral carotid stenosis that was revascularized (endarterectomy or stenting) or with ipsilateral, potentially causal intracranial stenosis ≥70%) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event
- and documented atherosclerotic stenosis:
- presence of carotid atherosclerotic stenosis (on the basis of carotid duplex, CTA, MRA, XRA - only the report will be required to document atherosclerotic disease) ipsilateral to the cerebral ischemic symptoms (stenosis defined by luminal narrowing ≥30%, judgement of the investigator)
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- or presence of atherosclerotic stenosis of another cerebral artery (documented vertebral artery stenosis, basilar artery stenosis, other intracranial artery stenosis) ipsilateral to the ischemic area (stenosis defined by luminal narrowing ≥30%, judgement of the investigator)
- or presence of atherosclerotic disease of the aortic arch with a plaque ≥4mm in thickness with or without superimposed thrombus, or a plaque <4 mm with a superimposed mobile thrombus (detected by transesophageal echocardiography or CT angiography)
- with no clear indication of colchicine treatment (gout, Mediterranean fever) and with an indication to long-term antiplatelet therapy (no clear indication to oral anticoagulant)
- age equal or above 18
- Rankin score less than ≤4 (ranges from 0 to 6, with 0 indicating no symptoms, 1 no disability, 2 to 3 needing some help with daily activities, 4 to 5 dependent or bedridden, and 6 death),
- fully informed and signed inform consent
- with social security number.
- medical examination before the participation to the research
- Under contraception in case of childbearing potential (highly effective: 1) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation et 2) progestogen-only).
- Pregnancy test for women of childbearing potential
Who cannot join
- Colchicine treatment needed (e.g., gout, Mediterranean fever)
- Hypersensitivity to ticagrelor or any of the excipients.
- Hypersensitivity to colchicine or any of the excipients.
- Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
- Immunosuppression, medullary aplasia
- Active chronic inflammatory disease, chronic active infection, evolving cancer
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- Hemodynamic instability (need for amines for more than 24 hours, circulatory assistance)
- A recent severe sepsis (7 days) or all recent acute reaches
- Chronic treatment (for more than 6 months) with corticosteroids or NSAIDs (or repeated high-dose intake for less than 7 days).
- Anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or CYP3A4 substrates than cannot be stopped for the course of the course of this study
- CI/TIA due to arterial dissection (as documented following the judgment of the investigator) or due to cardiac source of embolism without documented atherosclerotic disease (e.g., mitral stenosis or endomyocardial fibrosis, endocarditis) a patient with atrial fibrillation, or with a history of myocardial infarction, or with calcified aortic stenosis will be eligible if the above inclusion criteria are also met]
- Indication to long-term oral anticoagulant treatment (e.g., atrial fibrillation)
- Symptomatic hemorrhagic stroke (the mere presence of asymptomatic cerebral hemosiderin deposits -so called "microbleedings" - on gradient echo imaging is not an exclusion criteria)
- Active pathological bleeding
- Uncontrolled hypertension (investigator judgement)
- Follow-up visit impossible or anticipated bad compliance.
- Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits..
- Anticipated pregnancy at time of enrollment in the study
- Breastfeeding woman
- Patients participating in another pharmaco therapeutic program with an experimental therapy that is known to affect the ticagrerlor, colchicine or aspirine therapy.
- Leukopenia <3000/μl
- Patients with severe renal impairment (creatinine clearance < 30 ml/min)
- Patients with severe hepatic impairment
- Prohibited treatments: All treatments contraindicated during the use of colchicine and/or ticagrelor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
URC Lariboisière-Fernand Widal-Saint Louis
Paris, Paris, 75010
Brahim M Elarbi, 01 40 05 43 60 ext. +33, brahim.mohamed-elarbi@aphp.fr
Pierre Amarenco, Pr
About this study
Official title: Reducing Inflammation in Ischemic Stroke With Colchicine, and Ticagrelor in High-risk Patients-extended Treatment in Ischemic Stroke
REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.
Read the detailed description
Our main hypothesis is that low-dose colchicine (0.5 mg/day) on top of best medical care, in patients with an ischemic stroke with ipsilateral atherosclerotic stenosis, will reduce the risk of major vascular events after 36-60 months of treatment as compared to no colchicine.
Our second main hypothesis, tested in 2x2 factorial design, is that ticagrelor 90 mg bid in the same patients, will reduce the long-term risk of major vascular events (after 36-60 months of treatment) as compared to aspirin 75-300 mg/day.
- Conditions
- Stroke, Stroke, Ischemic, Atherosclerosis, Myocardial Infarction, Coronary Syndrome, TIA
- Being tested
- Colchicine 0.5 MG, Ticagrelor 90mg, Aspirin 75-300mg
- Keywords
- Stroke, Colchicine, Atherosclerosis, Aspirin, Ticagrelor
- Medical subject headings
- Stroke, Ischemic Stroke, Atherosclerosis, Myocardial Infarction, Angina, Unstable, Heart Diseases, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Colchicine is a medication used to treat gout and Behçet's disease. In gout, it is less preferred to NSAIDs or steroids. Other uses for colchicine include the management of pericarditis and familial Mediterranean fever.
Ticagrelor 90mgDrug
Also called Brilinta
Ticagrelor, sold under the brand name Brilinta among others, is a medication used for the prevention of stroke, heart attack and other events in people with acute coronary syndrome, meaning problems with blood supply in the coronary arteries. It acts as a platelet aggregation inhibitor by antagonising the P2Y 12 receptor.
Aspirin 75-300mgDrug
Also called Acetylsalicylic acid
Also known as Aspirin, acetylsalicylic acid (ASA) is a commonly used drug for the treatment of pain and fever due to various causes. Acetylsalicylic acid has both anti-inflammatory and antipyretic effects. This drug also inhibits platelet aggregation and is used in the prevention of blood clots stroke, and myocardial infarction (MI).
| Study group | Role | What they receive |
|---|---|---|
| Colchicine + Ticagrelor | Experimental | Not described Receives: Drug: Colchicine 0.5 MG; Drug: Ticagrelor 90mg |
| Colchine + Aspirine | Experimental | Not described Receives: Drug: Colchicine 0.5 MG; Drug: Aspirin 75-300mg |
| SOC + Ticagrelor | Experimental | Not described Receives: Drug: Ticagrelor 90mg |
| SOC + Aspirine | Active comparator | Not described Receives: Drug: Aspirin 75-300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with nonfatal ischemic stroke
Sudden onset of focal neurologic symptoms related to impaired cerebral circulation. ASCOD phenotyping will be used. TIAs will not be part of strokes. However, any focal neurologic symptoms associated with positive DWI or hypodensity on the CT scan in an appropriate area in relation with these symptoms will be considered a cerebral infarction and be part of "strokes".
Measured: 36 months
Number of Participants with undetermined stroke
Sudden onset of focal neurologic symptoms related to impaired cerebral circulation. ASCOD phenotyping will be used. TIAs will not be part of strokes. However, any focal neurologic symptoms associated with positive DWI or hypodensity on the CT scan in an appropriate area in relation with these symptoms will be considered a cerebral infarction and be part of "strokes".
Measured: 36 months
Number of Participants with nonfatal myocardial infarction
- Fatal or nonfatal myocardial infarction (OMS.AHA/ACC definition)
- Clinical symptoms + elevated troponin
- Silent myocardial infarction following universal definition
Measured: 36 months
Number of Participants with urgent coronary or carotid revascularization following new symptoms
Revascularization Procedure
- Coronary : Angioplasty or stenting or CABG
- Carotid : angioplasty or stenting, surgical endarterectomy
- Peripheral: angioplasty or stenting including aorta, surgical by-pass or endarterectomy of a peripheral artery.
Measured: 36 months
Number of Participants with vascular death including sudden death
- Vascular death
- Death due to cardiac or vascular cause
- Death due to systemic hemorrhage
- Death due to pulmonary embolism
- Sudden death: death occurring within 24 hours, unexpected in a patient in apparent healthy condition or condition that was stable or improved
- Death without documented nonvascular cause
- Fatal stroke: death occurring within 30 days of stroke onset (whether ischemic or hemorrhagic).
Measured: 36 months
Secondary outcomes (11)
Number of Participants with recurrent fatal and nonfatal ischemic stroke
Measured: 36 months
Number of Participants with urgent carotid revascularization following a new transient ischemic attack with negative neuro-imaging
Measured: 36 months
Number of Participants with fatal and nonfatal myocardial infarction
Measured: 36 months
Number of Participants with fatal and nonfatal myocardial infarction or urgent coronary revascularization following a new acute coronary syndrome
Measured: 36 months
Number of Participants with vascular death
Measured: 36 months
Number of Participants with any stroke or TIA
A TIA is defined by sudden onset of neurologic symptoms presumed of ischemic origin, with total resolution, being clearly related to focal cerebral or retinal involvement, and with negative neuro-imaging in the cerebral area corresponding to the symptoms. TIA diagnosis must be confirmed by a neurologist, based on clinical and negative neuro-imaging evaluation (MRI with DWI is recommended).
Measured: 36 months
Number of Participants with major coronary events
Measured: 36 months
Number of Participants with any coronary end-points (MI, hospitalization for recurrent ACS, coronary revascularization procedure urgent or elective, fatal coronary event)
ACS: Acute Coronary Syndrome
Measured: 36 months
Number of death participant (any death)
Measured: 36 months
Number of Participant with all revascularization procedures (coronary, carotid, peripheral)
Measured: 36 months
Number of Participants with Carotid revascularization
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start17 May 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476991
- Sponsor's protocol ID
- APHP211055
- Acronym
- RIISC-THETIS
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inflammation in Ischemic Stroke With Colchicine, and Ticagrelor in High-risk Patients-extended Treatment in Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05476991
- Acronym / sponsor ID
- RIISC-THETIS / APHP211055
- Conditions
- Stroke, Stroke, Ischemic, Atherosclerosis, Myocardial Infarction, Coronary Syndrome, TIA
- Keywords
- Stroke, Colchicine, Atherosclerosis, Aspirin, Ticagrelor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Jul 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.
REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.
Detailed description
Our main hypothesis is that low-dose colchicine (0.5 mg/day) on top of best medical care, in patients with an ischemic stroke with ipsilateral atherosclerotic stenosis, will reduce the risk of major vascular events after 36-60 months of treatment as compared to no colchicine.
Our second main hypothesis, tested in 2x2 factorial design, is that ticagrelor 90 mg bid in the same patients, will reduce the long-term risk of major vascular events (after 36-60 months of treatment) as compared to aspirin 75-300 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Colchicine + Ticagrelor | Experimental | Drug: Colchicine 0.5 MG, Drug: Ticagrelor 90mg |
| Colchine + Aspirine | Experimental | Drug: Colchicine 0.5 MG, Drug: Aspirin 75-300mg |
| SOC + Ticagrelor | Experimental | Drug: Ticagrelor 90mg |
| SOC + Aspirine | Active comparator | Drug: Aspirin 75-300mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Cerebral infarction (CI) proven by neuro-imaging (MRI or head-CT), immediately once the neurologic deficit is stabilized (investigator judgement) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event (TIA with documented ischemic lesion (MRI or CT) in the appropriate area corresponding to the symptoms will be considered CI, following the current definition)
- Or TIA lasting more 10 minutes or more (with motor symptoms or aphasia/dysarthria or visual defect), with total resolution and no brain lesion on neuro-imaging (TIA) and with ipsilateral carotid stenosis that was revascularized (endarterectomy or stenting) or with ipsilateral, potentially causal intracranial stenosis ≥70%) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event
- and documented atherosclerotic stenosis:
- with no clear indication of colchicine treatment (gout, Mediterranean fever) and with an indication to long-term antiplatelet therapy (no clear indication to oral anticoagulant)
- age equal or above 18
Key exclusion criteria (24 listed)
- Colchicine treatment needed (e.g., gout, Mediterranean fever)
- Hypersensitivity to ticagrelor or any of the excipients.
- Hypersensitivity to colchicine or any of the excipients.
- Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
- Immunosuppression, medullary aplasia
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 |
|---|---|---|
| Colchicine 0.5 MGColchicine is a medication used to treat gout and Behçet's disease. In gout, it is less preferred to NSAIDs or steroids. Other uses for colchicine include the management of pericarditis and familial Mediterranean fever. | Drug | Colchicine + Ticagrelor, Colchine + Aspirine |
| Ticagrelor 90mgAlso: BrilintaTicagrelor, sold under the brand name Brilinta among others, is a medication used for the prevention of stroke, heart attack and other events in people with acute coronary syndrome, meaning problems with blood supply in the coronary arteries. It acts as a platelet aggregation inhibitor by antagonising the P2Y 12 receptor. | Drug | Colchicine + Ticagrelor, SOC + Ticagrelor |
| Aspirin 75-300mgAlso: Acetylsalicylic acidAlso known as Aspirin, acetylsalicylic acid (ASA) is a commonly used drug for the treatment of pain and fever due to various causes. Acetylsalicylic acid has both anti-inflammatory and antipyretic effects. This drug also inhibits platelet aggregation and is used in the prevention of blood clots stroke, and myocardial infarction (MI). | Drug | Colchine + Aspirine, SOC + Aspirine |
Primary outcome
Number of Participants with nonfatal ischemic stroke
Time frame: 36 months
Sudden onset of focal neurologic symptoms related to impaired cerebral circulation. ASCOD phenotyping will be used. TIAs will not be part of strokes. However, any focal neurologic symptoms associated with positive DWI or hypodensity on the CT scan in an appropriate area in relation with these symptoms will be considered a cerebral infarction and be part of "strokes".
Number of Participants with undetermined stroke
Time frame: 36 months
Sudden onset of focal neurologic symptoms related to impaired cerebral circulation. ASCOD phenotyping will be used. TIAs will not be part of strokes. However, any focal neurologic symptoms associated with positive DWI or hypodensity on the CT scan in an appropriate area in relation with these symptoms will be considered a cerebral infarction and be part of "strokes".
Number of Participants with nonfatal myocardial infarction
Time frame: 36 months
* Fatal or nonfatal myocardial infarction (OMS.AHA/ACC definition) o Clinical symptoms + elevated troponin * Silent myocardial infarction following universal definition
Number of Participants with urgent coronary or carotid revascularization following new symptoms
Time frame: 36 months
Revascularization Procedure * Coronary : Angioplasty or stenting or CABG * Carotid : angioplasty or stenting, surgical endarterectomy * Peripheral: angioplasty or stenting including aorta, surgical by-pass or endarterectomy of a peripheral artery.
Number of Participants with vascular death including sudden death
Time frame: 36 months
- Vascular death * Death due to cardiac or vascular cause * Death due to systemic hemorrhage * Death due to pulmonary embolism * Sudden death: death occurring within 24 hours, unexpected in a patient in apparent healthy condition or condition that was stable or improved * Death without documented nonvascular cause * Fatal stroke: death occurring within 30 days of stroke onset (whether ischemic or hemorrhagic).
11 secondary outcomes
Number of Participants with recurrent fatal and nonfatal ischemic stroke
Time frame: 36 months
Number of Participants with urgent carotid revascularization following a new transient ischemic attack with negative neuro-imaging
Time frame: 36 months
Number of Participants with fatal and nonfatal myocardial infarction
Time frame: 36 months
Number of Participants with fatal and nonfatal myocardial infarction or urgent coronary revascularization following a new acute coronary syndrome
Time frame: 36 months
Number of Participants with vascular death
Time frame: 36 months
Number of Participants with any stroke or TIA
Time frame: 36 months
Number of Participants with major coronary events
Time frame: 36 months
Number of Participants with any coronary end-points (MI, hospitalization for recurrent ACS, coronary revascularization procedure urgent or elective, fatal coronary event)
Time frame: 36 months
Number of death participant (any death)
Time frame: 36 months
Number of Participant with all revascularization procedures (coronary, carotid, peripheral)
Time frame: 36 months
Number of Participants with Carotid revascularization
Time frame: 36 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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG, Ticagrelor 90mg and Aspirin 75-300mg in people with Stroke and Stroke, Ischemic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 16 inclusion and 24 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 8 Sep 2025. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Pierre Amarenco, Pr (140258725 ext. +33, pierre.amarenco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with nonfatal ischemic stroke (time frame: 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.