Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021953-37 | EudraCT Number | ||
| 2010/1971 | Registry Identifier | REK | |
| 10/15070-4 | Registry Identifier | SLV | |
| 4947 | Other Grant/Funding Number | HSØ | |
| 2010/19043 | Other Identifier | PVO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| South-Eastern Norway Regional Health Authority | OTHER |
| University of Oslo | OTHER |
| Norwegian University of Science and Technology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaCl 0.9% 100 ml | Placebo Comparator |
| |
| Tocilizumab 280 mg | Experimental | Intravenous infusion, 280 mg Tocilizumab (14 ml) added to 86 ml of 0.9% NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab 280 mg | Drug | Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl |
|
| Measure | Description | Time Frame |
|---|---|---|
| high sensitivity C-reactive protein Area under the curve (AUC) | 0-56 hrs following inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| hs troponin T | 0-56 hrs, 3 months and 6 months following inclusion | |
| hs CRP | 3 and 6 months following inclusion | |
| pro-BNP |
| Measure | Description | Time Frame |
|---|---|---|
| Other inflammatory pathways | TNF-alfa, IL-1, IL-6, IL-18, platelet-derived inflammatory mediators, anti-inflammatory cytokines etc | 0-56 hrs, 3 monhts, 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Gullestad, MD, PhD | Oslo University Hospital | Principal Investigator |
| Rune Wiseth, MD, PhD | St. Olavs Hospital | Study Chair |
| Pål Aukrust, MD, PhD | Oslo University Hospital | Study Chair |
| Jan K Damås, MD, PhD | St. Olavs Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0424 | Norway | ||
| St Olavs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39073758 | Derived | 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. | |
| 30258647 | Derived | Ueland 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| NaCl 0.9% 100 ml | Drug | Placebo |
|
| 0-56 hrs, 3 and 6 months |
| Infarct size | Assessed by Echocardiography and MRI at 6 months | 6 months |
| LV size | Assessed by echocardiography | acute phase (0-3 days), 6 months |
| LV function | Assessed by echocardiography, cardiac MRI at 6 months | acute phase (0-3 days), 6 months |
| Coronary flow reserve | Assesses coronary microvascular function - for 60 patients only. | acute phase (0-3 days), 6 months |
| Endothelial function | Assessed by tonometry | Acute phase (0-3 days) and 6 months |
| Trondheim |
| Sør-Trøndelag |
| 7006 |
| Norway |
| 29961572 | Derived | Kleveland 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |