EUCTR2010-024616-33-SE
Active, not recruiting
Not Applicable
Phase II, multicenter, randomized, double-blind, placebo controlled study to assess safety and efficacy of TRO40303 for reduction of reperfusion injury in patients undergoing Percutaneous Coronary Intervention for acute myocardial infarction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- TROPHOS SA
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and Female with non child\-bearing potential (post menopausal, ovariectomised or hysterectomised) patients. Menopause is defined as age \> 60 years, or between 45 and 60 years being amenorrheic for at least 2 years.
- •2\.Age\>18 years old
- •3\.First acute myocardial infarction
- •4\.Occlusion should affect the following coronaries: the Left Anterior Descending artery (LAD) or the dominant or balanced Right Coronary Artery (RCA) or the dominant or balanced left circumflex artery (LCx).
- •5\.Acute myocardial infarction defined as
- •a)nitrate resistant chest pain \= 30 min
- •b)ST\-segment elevation \= 2 mm in at least two contiguous chest leads. This inclusion criterion regarding ST elevation can be superseded by inclusion criterion 7\.
- •6\.Presenting within 6h of onset of chest pain
- •7\.Clinical decision to treat with percutaneous coronary intervention
- •8\.Occlusion of culprit artery with a Thrombolysis In Myocardial Infarction (TIMI) flow grade 0\-1 at time of admission and before percutaneous coronary intervention.
Exclusion Criteria
- •1\.Cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous AMI, angina within 48h before infarction, previous CABG, treatment with intravenous fibrinolytic therapy within the 72 hours prior to PCI.
- •2\.Atrial fibrillation (could confound CMR analysis)
- •3\.Pace\-maker
- •4\.Concurrent inflammatory, infectious or malignant disease
- •5Biliary obstruction or hepatic insufficiency at the time of inclusion in the study based on patient questioning
- •6\.Be possibly dependant on the Investigator or the Sponsor (eg including but not limited to affiliated employee)
- •7\.Participated in any other international drug or therapy study with a non\-approved medication, within the previous 3 months.
- •8\.Patient under guardianship
- •9\. History or presence of egg allergy based upon patient questioning
Outcomes
Primary Outcomes
Not specified
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