Safety and efficacy study of TRO40303 for reduction of reperfusion injury in patients undergoing Percutaneous Coronary Intervention for acute myocardial infarctio
- Conditions
- Treatment for cardiac reperfusion injury in patients undergoing PCI( Percutaneous coronary intervention) to treat an AMI (Acute Myocardial Infarction) and to assess safety as well as the ability of TRO40303 to reduce infarct size using biomarkers and MRI (Magnetic Resonance Imaging)MedDRA version: 16.0Level: LLTClassification code 10000930Term: Acute myocardial infarction, unspecified site, initial episode of careSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-024616-33-SE
- Lead Sponsor
- TROPHOS SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 This inclusion criterion regarding ST elevation can be superseded by inclusion criterion 7.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.
9.Have signed an Informed Consent to participate to the trial before any study related procedure has been taken.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method