Safety and efficacy study of TRO40303 for reduction of reperfusion injury in patients undergoing Percutaneous Coronary Intervention for acute myocardial infarctio

Phase 1

Active, not recruiting

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: 14.1Level: LLTClassification code 10000930Term: Acute myocardial infarction, unspecified site, initial episode of careSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-024616-33-DK

Lead Sponsor: TROPHOS SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 180

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 This inclusion criterion regarding ST elevation can be superseded by inclusion criterion 7.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.
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

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
5.Biliary obstruction or hepatic insufficiency
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to assess the efficacy of TRO40303 administered just before balloon inflation during percutaneous coronary intervention (PCI) to reduce infarct size due to reperfusion injury in patients treated for acute myocardial infarction (AMI).;Secondary Objective: The secondary objectives of this trial is to assess the safety of TRO40303 ;Primary end point(s): Co-Primary endpoints: Infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and AUC of troponin I ;Timepoint(s) of evaluation of this end point: blood sampling every 6 hours during 72 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - infarct size normalized to the myocardium at risk assessed by CMR. <br>-Left ventricular function after PCI will be assessed by CMR and echocardiography performed between D3 and D5, echocardiography being repeated at Day 30.<br>-An assessment of ST-segment decrease after PCI will be performed by comparing the pre-PCI ECG to an ECG performed one hour post stenting. <br>-The amount of microvascular obstruction will be assessed by CMR.<br>-Transmural extension of infarct will be assessed by CMR.<br>;Timepoint(s) of evaluation of this end point: -CMR :Between D3 and D5 <br>-Echocardiography : between D3 and D5 , repeated at D30<br>-ECG : Pre-PCI and one hour post stenting

Related Trials