Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)
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.
Drug: Ilomedin and standard low dose treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Bleeding complications as evaluated by TIMI and GUSTO criteria [ Time Frame: Feb 2011 ] [ Designated as safety issue: Yes ]Increased bleeding complications will be evaluated between the active and placebo groups.
- Endothelial markers and blood aggregation (measured by TEG and multiplate) [ Time Frame: Feb 2011 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Ilomedin and standard low dose treatment||
Other Name: IloprostDrug: Ilomedin Drug: Ilomedin and standard low dose treatment
|Placebo Comparator: Placebo||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179776
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Lene Holmvang, MD||Rigshospitalet, Denmark|