Acute Coronary SyndromesIVORY-FINALENCT06427694
Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study
An observational study of Acute Coronary Syndromes, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Aldesleukin and Dextrose 5% in water
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to 11 Feb 2030
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of the IVORY trial (NCT04241601) and who consented to be contacted for future research received all scheduled doses of either placebo or IL2 and are alive at the time of data collection will be approached.
Who may be able to join
- Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses
Who cannot join
- Patients who decline participation
- Patients who did not consent to being contacted about future research
- Patients who were withdrawn from the IVORY trial for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB20QQ
Joseph Cheriyan, MBChB,FRCP, 0044 1223 256653, jc403@medschl.cam.ac.uk
Joseph Cheriyan, MBChB, FRCP
About this study
Official title: The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study
The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.
In this follow-up study, the investigators aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.
Read the detailed description
A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart, due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack.
The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function. Aldesleukin, also known as interleukin-2 (IL2), is a medicine that stimulates the production of Treg cells when given at low doses. The effectiveness of IL2 in influencing the immune system was tested in a phase 2 trial, IVORY.
Participants were recruited to the IVORY trial following a sudden narrowing/blockages in walls of blood vessels to the heart resulting in a heart attack (Acute Coronary Syndrome (ACS)). Participants were randomised to receive either low dose IL2 or placebo, researchers and participants were blinded to the treatment allocation. Participants underwent two PET/CT (Positron emission tomography-computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Aldesleukin, Dextrose 5% in water
- Keywords
- Acute Coronary Syndromes
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinDrug
Also called Proleukin
IL2 antagonist
Dextrose 5% in waterDrug
Also called Dextrose
matched placebo to active
| Study group | Role | What they receive |
|---|---|---|
| Aldesleukin | Aldesleukin loading dose 1.5 x 10^6 IU followed by maintenance dose of 1.5 x 10^6 IU Receives: Drug: Aldesleukin | |
| Placebo | Dextrose 5% Receives: Drug: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular outcomes
Number of major adverse cardiovascular outcomes
Measured: 1 year from when initially dosed in preceding IVORY trial
Major adverse cardiovascular outcomes
Number of major adverse cardiovascular outcomes
Measured: 2 years from when initially dosed in preceding IVORY trial
Major adverse cardiovascular outcomes
Number of major adverse cardiovascular outcomes
Measured: 5 years from when initially dosed in preceding IVORY trial
Secondary outcomes (39)
Death due to cardiovascular causes
Number of deaths due to cardiovascular causes comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Deaths due to cardiovascular causes comparing IL2 to placebo
Number of deaths due to cardiovascular causes comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Deaths due to cardiovascular causes comparing IL2 to placebo
Number of deaths due to cardiovascular causes comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Resuscitated cardiac arrests comparing IL2 to placebo
Numbers of resuscitated cardiac arrests comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Resuscitated cardiac arrests comparing IL2 to placebo
Numbers of resuscitated cardiac arrests comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Resuscitated cardiac arrests comparing IL2 to placebo
Numbers of resuscitated cardiac arrests comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Ischaemic strokes comparing IL2 to placebo
Number of ischaemic strokes comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Ischaemic strokes comparing IL2 to placebo
Number of ischaemic strokes comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Ischaemic strokes comparing IL2 to placebo
Number of ischaemic strokes comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Unplanned coronary vascularisations comparing IL2 to placebo
Number of unplanned coronary vascularisations comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Unplanned coronary vascularisations comparing IL2 to placebo
Number of unplanned coronary vascularisations comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Unplanned coronary vascularisations comparing IL2 to placebo
Number of unplanned coronary vascularisations comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Hospitalisations due to cardiovascular causes comparing IL2 to placebo
Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Hospitalisations due to cardiovascular causes comparing IL2 to placebo
Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Hospitalisations due to cardiovascular causes comparing IL2 to placebo
Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
All-cause deaths comparing IL2 to placebo
Number of all-cause deaths comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
All-cause death comparing IL2 to placebo
Number of all-cause deaths comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
All-cause death comparing IL2 to placebo
Number of all-cause deaths comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure)comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Number of hospitalisation due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Revascularisations for peripheral vascular disease comparing IL2 to placebo
Number of revascularisations for peripheral vascular disease comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Revascularisations for peripheral vascular disease comparing IL2 to placebo
Number of revascularisations for peripheral vascular diseasecomparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Revascularisations for peripheral vascular disease comparing IL2 to placebo
Number of revascularisations for peripheral vascular disease comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Amputations due to peripheral vascular disease comparing IL2 to placebo
Number of amputations due to peripheral vascular disease comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Amputations due to peripheral vascular disease comparing IL2 to placebo
Number of amputations due to peripheral vascular disease comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Amputations due to peripheral vascular disease comparing IL2 to placebo
Number of amputations due to peripheral vascular disease comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Haemorrhagic strokes comparing IL2 to placebo
Number of haemorrhagic strokes comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Haemorrhagic strokes comparing IL2 to placebo
Number of haemorrhagic strokes comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Haemorrhagic strokes comparing IL2 to placebo
Number of haemorrhagic strokes comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
New atrial fibrillation diagnosis comparing IL2 to placebo
Number of new atrial fibrillation diagnoses comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
New atrial fibrillation diagnosis comparing IL2 to placebo
Number of new atrial fibrillation diagnoses comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
New atrial fibrillation diagnosis comparing IL2 to placebo
Number of new atrial fibrillation diagnoses comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Measured: 1 year from when initially dosed in preceding IVORY trial
Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Measured: 2 years from when initially dosed in preceding IVORY trial
Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Measured: 5 years from when initially dosed in preceding IVORY trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jun 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion11 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBChB, FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427694
- Sponsor's protocol ID
- IVORY-FINALE (A096877)
- Other IDs
- 339102
- Acronym
- IVORY-FINALE
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On completion of the study the data will be analysed and tabulated and a Final Study Report prepared. Data will be published in an open access journal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study
- ClinicalTrials.gov ID
- NCT06427694
- Acronym / sponsor ID
- IVORY-FINALE / IVORY-FINALE (A096877)
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 11 Feb 2030 (estimated)
- First posted
- 24 May 2024 (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.
The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.
In this follow-up study, the investigators aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.
Detailed description
A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart, due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack.
The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function. Aldesleukin, also known as interleukin-2 (IL2), is a medicine that stimulates the production of Treg cells when given at low doses. The effectiveness of IL2 in influencing the immune system was tested in a phase 2 trial, IVORY.
Participants were recruited to the IVORY trial following a sudden narrowing/blockages in walls of blood vessels to the heart resulting in a heart attack (Acute Coronary Syndrome (ACS)). Participants were randomised to receive either low dose IL2 or placebo, researchers and participants were blinded to the treatment allocation. Participants underwent two PET/CT (Positron emission tomography-computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aldesleukin | – | Drug: AldesleukinAldesleukin loading dose 1.5 x 10^6 IU followed by maintenance dose of 1.5 x 10^6 IU |
| Placebo | – | Drug: Dextrose 5% in waterDextrose 5% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the IVORY trial (NCT04241601) and who consented to be contacted for future research received all scheduled doses of either placebo or IL2 and are alive at the time of data collection will be approached.
Key inclusion criteria (1 listed)
- Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses
Key exclusion criteria (3 listed)
- Patients who decline participation
- Patients who did not consent to being contacted about future research
- Patients who were withdrawn from the IVORY trial for any reason
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 |
|---|---|---|
| AldesleukinAlso: ProleukinIL2 antagonist | Drug | Aldesleukin |
| Dextrose 5% in waterAlso: Dextrosematched placebo to active | Drug | Placebo |
Primary outcome
Major adverse cardiovascular outcomes
Time frame: 1 year from when initially dosed in preceding IVORY trial
Number of major adverse cardiovascular outcomes
Major adverse cardiovascular outcomes
Time frame: 2 years from when initially dosed in preceding IVORY trial
Number of major adverse cardiovascular outcomes
Major adverse cardiovascular outcomes
Time frame: 5 years from when initially dosed in preceding IVORY trial
Number of major adverse cardiovascular outcomes
39 secondary outcomes
Death due to cardiovascular causes
Time frame: 1 year from when initially dosed in preceding IVORY trial
Deaths due to cardiovascular causes comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Deaths due to cardiovascular causes comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Resuscitated cardiac arrests comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Resuscitated cardiac arrests comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Resuscitated cardiac arrests comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Ischaemic strokes comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Ischaemic strokes comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Ischaemic strokes comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Unplanned coronary vascularisations comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Unplanned coronary vascularisations comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Unplanned coronary vascularisations comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Hospitalisations due to cardiovascular causes comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Hospitalisations due to cardiovascular causes comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Hospitalisations due to cardiovascular causes comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
All-cause deaths comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
All-cause death comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
All-cause death comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Revascularisations for peripheral vascular disease comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Revascularisations for peripheral vascular disease comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Revascularisations for peripheral vascular disease comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Amputations due to peripheral vascular disease comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Amputations due to peripheral vascular disease comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Amputations due to peripheral vascular disease comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Haemorrhagic strokes comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Haemorrhagic strokes comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Haemorrhagic strokes comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
New atrial fibrillation diagnosis comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
New atrial fibrillation diagnosis comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
New atrial fibrillation diagnosis comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Time frame: 1 year from when initially dosed in preceding IVORY trial
Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Time frame: 2 years from when initially dosed in preceding IVORY trial
Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo
Time frame: 5 years from when initially dosed in preceding IVORY trial
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 10 Jun 2024.
- Individual participant dataSharing planned: No. On completion of the study the data will be analysed and tabulated and a Final Study Report prepared. Data will be published in an open access journal.
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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.
Joseph Cheriyan, MBChB, FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 3 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 10 Jun 2024. 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 Kingdom. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular outcomes (time frame: 1 year from when initially dosed in preceding IVORY trial). The study lists 3 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 10 Jun 2024.