Non-ST Elevation Myocardial InfarctionPhase 2NCT01491074
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction
A Phase 2 study testing Tocilizumab 280 mg and NaCl 0.9% 100 ml in people with Non-ST Elevation Myocardial Infarction, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Acute coronary syndromes (ACS) are still associated with high morbidity and mortality, despite several improvements in their management. This may indicate that important pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction
- What is being tested?
- Tocilizumab 280 mg and NaCl 0.9% 100 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2011to Apr 2014
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NSTEMI (ESC Type 1)
- Age 18-80 years
- Troponin T >/= 30 ng/ml
- Informed consent to participation
Who cannot join
- STEMI
- Known cardiac disease, except coronary disease (cardiomyopathy, heart failure with known EF < 45%, severe valvular heart disease attending regular follow-up, recent PCI/ACB (< 3 months))
- Hemodynamic and/or respiratory instability
- Cardiac arrest in acute phase
- Concurrent condition affecting/potentially affecting CRP (infection, malignancy, autoimmune disease)
- Recent major surgery (< 3 months)
Show all 11Show fewer
- Recent/concurrent immunosuppressant treatment (< 2 weeks, except NSAIDs)
- Severe renal failure (eGFR < 30 ml/min)
- Pregnancy
- Contraindications to any study investigations and/or medication.
- Expected non-adherence to study protocol
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo, Oslo, 0424
St Olavs Hospital
Trondheim, Sør-Trøndelag, 7006
About this study
Official title: Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized, Double Blind, Placebo Controlled Study.
Acute coronary syndromes (ACS) are still associated with high morbidity and mortality, despite several improvements in their management. This may indicate that important pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.
Based upon previous research, the investigators believe that providing a block in the damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling, could be an attractive therapeutic target in ACS; and of particular interest in patients with non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread coronary inflammation with multiple unstable plaques.
Read more
The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating inflammatory loops which could improve plaque stability, with potential secondary beneficial effects on myocardial damage.
This will be investigated in a randomized, double blind, placebo-controlled study, including a total of 120 patients.
- Conditions
- Non-ST Elevation Myocardial Infarction
- Being tested
- Tocilizumab 280 mg, NaCl 0.9% 100 ml
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab 280 mgDrug
Also called Brand name RoActemra (Roche), ATC: L04A C07
Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl
NaCl 0.9% 100 mlDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NaCl 0.9% 100 ml | Placebo comparator | Not described Receives: Drug: NaCl 0.9% 100 ml |
| Tocilizumab 280 mg | Experimental | Intravenous infusion, 280 mg Tocilizumab (14 ml) added to 86 ml of 0.9% NaCl Receives: Drug: Tocilizumab 280 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
high sensitivity C-reactive protein Area under the curve (AUC)
Measured: 0-56 hrs following inclusion
Secondary outcomes (8)
hs troponin T
Measured: 0-56 hrs, 3 months and 6 months following inclusion
hs CRP
Measured: 3 and 6 months following inclusion
pro-BNP
Measured: 0-56 hrs, 3 and 6 months
Infarct size
Assessed by Echocardiography and MRI at 6 months
Measured: 6 months
LV size
Assessed by echocardiography
Measured: acute phase (0-3 days), 6 months
LV function
Assessed by echocardiography, cardiac MRI at 6 months
Measured: acute phase (0-3 days), 6 months
Coronary flow reserve
Assesses coronary microvascular function - for 60 patients only.
Measured: acute phase (0-3 days), 6 months
Endothelial function
Assessed by tonometry
Measured: Acute phase (0-3 days) and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, South-Eastern Norway Regional Health Authority, University of Oslo, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Lars Gullestad, MD, PhD, Principal investigator, Oslo University HospitalRune Wiseth, MD, PhD, Study chair, St. Olavs HospitalPål Aukrust, MD, PhD, Study chair, Oslo University HospitalJan K Damås, MD, PhD, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491074
- Sponsor's protocol ID
- 2010/1971 [REK]
- Other IDs
- 2010-021953-37, 2010/1971, 10/15070-4, 4947, 2010/19043
- Status last verified
- May 2014
- First submitted
- 9 Dec 2011
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aherrahrou R, Reinberger T, Hashmi S, Erdmann J. GWAS breakthroughs: mapping the journey from one locus to 393 significant coronary artery disease associations. Cardiovasc Res. 2024 Nov 5;120(13):1508-1530. doi: 10.1093/cvr/cvae161.
PubMed 39073758Ueland T, Kleveland O, Michelsen AE, Wiseth R, Damas JK, Aukrust P, Gullestad L, Halvorsen B, Yndestad A. Serum PCSK9 is modified by interleukin-6 receptor antagonism in patients with hypercholesterolaemia following non-ST-elevation myocardial infarction. Open Heart. 2018 Sep 18;5(2):e000765. doi: 10.1136/openhrt-2017-000765. eCollection 2018.
PubMed 30258647Kleveland O, Ueland T, Kunszt G, Bratlie M, Yndestad A, Broch K, Holte E, Ryan L, Amundsen BH, Bendz B, Aakhus S, Espevik T, Halvorsen B, Mollnes TE, Wiseth R, Gullestad L, Aukrust P, Damas JK. Interleukin-6 receptor inhibition with tocilizumab induces a selective and substantial increase in plasma IP-10 and MIP-1beta in non-ST-elevation myocardial infarction. Int J Cardiol. 2018 Nov 15;271:1-7. doi: 10.1016/j.ijcard.2018.04.136. Epub 2018 Jun 29.
PubMed 29961572
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized, Double Blind, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT01491074
- Acronym / sponsor ID
- 2010/1971 [REK]
- Conditions
- Non-ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, South-Eastern Norway Regional Health Authority, University of Oslo, Norwegian University of Science and Technology
- Study start
- Aug 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Dec 2011 (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.
Acute coronary syndromes (ACS) are still associated with high morbidity and mortality, despite several improvements in their management. This may indicate that important pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.
Based upon previous research, the investigators believe that providing a block in the damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling, could be an attractive therapeutic target in ACS; and of particular interest in patients with non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread coronary inflammation with multiple unstable plaques.
The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating inflammatory loops which could improve plaque stability, with potential secondary beneficial effects on myocardial damage.
This will be investigated in a randomized, double blind, placebo-controlled study, including a total of 120 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaCl 0.9% 100 ml | Placebo comparator | Drug: NaCl 0.9% 100 ml |
| Tocilizumab 280 mg | Experimental | Drug: Tocilizumab 280 mgIntravenous infusion, 280 mg Tocilizumab (14 ml) added to 86 ml of 0.9% NaCl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NSTEMI (ESC Type 1)
- Age 18-80 years
- Troponin T >/= 30 ng/ml
- Informed consent to participation
Key exclusion criteria (11 listed)
- STEMI
- Known cardiac disease, except coronary disease (cardiomyopathy, heart failure with known EF < 45%, severe valvular heart disease attending regular follow-up, recent PCI/ACB (< 3 months))
- Hemodynamic and/or respiratory instability
- Cardiac arrest in acute phase
- Concurrent condition affecting/potentially affecting CRP (infection, malignancy, autoimmune disease)
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 |
|---|---|---|
| Tocilizumab 280 mgAlso: Brand name RoActemra (Roche), ATC: L04A C07Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl | Drug | Tocilizumab 280 mg |
| NaCl 0.9% 100 mlPlacebo | Drug | NaCl 0.9% 100 ml |
Primary outcome
high sensitivity C-reactive protein Area under the curve (AUC)
Time frame: 0-56 hrs following inclusion
8 secondary outcomes
hs troponin T
Time frame: 0-56 hrs, 3 months and 6 months following inclusion
hs CRP
Time frame: 3 and 6 months following inclusion
pro-BNP
Time frame: 0-56 hrs, 3 and 6 months
Infarct size
Time frame: 6 months
LV size
Time frame: acute phase (0-3 days), 6 months
LV function
Time frame: acute phase (0-3 days), 6 months
Coronary flow reserve
Time frame: acute phase (0-3 days), 6 months
Endothelial function
Time frame: Acute phase (0-3 days) and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Derived from this study: PubMed 39073758Aherrahrou R, Reinberger T, Hashmi S, Erdmann J. GWAS breakthroughs: mapping the journey from one locus to 393 significant coronary artery disease associations. Cardiovasc Res. 2024 Nov 5;120(13):1508-1530. doi: 10.1093/cvr/cvae161.
- Derived from this study: PubMed 30258647Ueland T, Kleveland O, Michelsen AE, Wiseth R, Damas JK, Aukrust P, Gullestad L, Halvorsen B, Yndestad A. Serum PCSK9 is modified by interleukin-6 receptor antagonism in patients with hypercholesterolaemia following non-ST-elevation myocardial infarction. Open Heart. 2018 Sep 18;5(2):e000765. doi: 10.1136/openhrt-2017-000765. eCollection 2018.
- Derived from this study: PubMed 29961572Kleveland O, Ueland T, Kunszt G, Bratlie M, Yndestad A, Broch K, Holte E, Ryan L, Amundsen BH, Bendz B, Aakhus S, Espevik T, Halvorsen B, Mollnes TE, Wiseth R, Gullestad L, Aukrust P, Damas JK. Interleukin-6 receptor inhibition with tocilizumab induces a selective and substantial increase in plasma IP-10 and MIP-1beta in non-ST-elevation myocardial infarction. Int J Cardiol. 2018 Nov 15;271:1-7. doi: 10.1016/j.ijcard.2018.04.136. Epub 2018 Jun 29.
Related trials for Non-ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
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.
Lars Gullestad, MD, PhD principal investigator
Oslo University Hospital
Rune Wiseth, MD, PhD study chair
St. Olavs Hospital
Pål Aukrust, MD, PhD study chair
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab 280 mg and NaCl 0.9% 100 ml in people with Non-ST Elevation Myocardial Infarction, run by Oslo University Hospital at 2 sites in Norway.
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 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
high sensitivity C-reactive protein Area under the curve (AUC) (time frame: 0-56 hrs following inclusion). 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 NCT01491074, which also lists 3 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 19 May 2014.