Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)

Study Overview
=================
Brief Summary
-----------------
Acute myocardial infarct patients with STEMI (ST-elevation on ECG) whom undergo a primary percutaneous cardiac intervention will following the standard treatment , received low dose of Ilomedin and to low dose of standard treatment for another 24 hours.

Official Title
-----------------
A Single Center, Open, Randomized, Placebo-controlled Study Investigating the Safety of Administration of Ilomedin® in Addition to Standard Treatment in Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)

Conditions
-----------------
Myocardial Infarct

Intervention / Treatment
-----------------
* Drug: Ilomedin
* Drug: Placebo
* Drug: Ilomedin
* Drug: Ilomedin and standard low dose treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Undergoing primary PCI due to STEMI (TIMI flow I -III before PCI and symptom duration < 12 hours) 6) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study data is used. - Exclusion Criteria: 2) Not able to give informed consent 3) Women with childbearing potential 4) On-going concomitant treatment with K-vitamin antagonists (one bolus dose pre-PCI allowed) 5) Known congenital or acquired coagulopathy and/or thrombocytopathy s 8) Participation in a clinical study and/or another investigational device within the past four weeks prior to Day 1 9) Major surgery or trauma within the past 6 weeks prior to Day 1 10) A blood coagulation disorder (i.e. international normalized ratio [INR] > 2.0, platelet count < 100,000/mm3, or hematocrit < 30%) 11) Renal insufficiency (creatinine > 140 mmol/l) 12) Major procedure related bleeding (TIMI major criteria); GI or urinary tract bleeding prior to inclusion in the trial 13) Known active hepatitis B and/or hepatitis C or HIV 14) Known or suspected hypersensitivity to components of the investigational medicinal product -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilomedin and standard low dose treatment<br> | Drug: Ilomedin<br>* Ilomedin<br>* Other names: Iloprost;Drug: Ilomedin<br> <br> Drug: Ilomedin and standard low dose treatment<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* i.v saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding complications as evaluated by TIMI and GUSTO criteria | Increased bleeding complications will be evaluated between the active and placebo groups. | Feb 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial markers and blood aggregation (measured by TEG and multiplate) | Endothelial markers will be measured to evaluate the Ilomedin effect on these patients. Blood aggregation and coagulation will be evaluated by using TEG and Multiplate. | Feb 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ST-eleveation, Myocardial infarct, Percutaneous coronary intervention, Myocardial infarct STEMI patients