Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01491074
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2011-12-09
Brief Title:
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized Double Blind Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201019043 | OTHER | PVO | None |
| 2010-021953-37 | EUDRACT_NUMBER | None | None |
| 20101971 | REGISTRY | None | None |
| 1015070-4 | REGISTRY | None | None |
| 4947 | OTHER_GRANT | None | None |