Percutaneous coronary intervention (PCI) due to an acute ischemic event MedDRA version: 12.1 Level: LLT Classification code 10066642 Term: Acute myocardial ischemia
Conditions
Interventions
Trade Name: Ilomedin®
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ILOPROST TROMETAMOL
CAS Number: 0
Current Sponsor code: NAP
Other descriptive name: NAP
Concentration unit: µg/ml
Sponsors
Rigshospitalet,Cardiology Laboratory 2013
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age > 18 years 2)Undergoing primary PCI due to STEMI (TIMI flow 0-III before PCI and symptom duration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Known HIV positive 2)Not able to give informed consent 3)Women with childbearing potential 4)Concomitant treatment with K-vitamin antagonists (one bolus dose pre-PCI allowed) 5)Known congenital or acquired coagulopathy and/or thrombocytopathy 6)Heparin treatment except for dose given pre-PCI treatment 7)Received within 30 days prior to Day 1 prostacyclin or GPIIIB/IIA inhibitors 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of administration of Ilomedin® for 24 hours after PCI in addition to standard treatment with regard to development of bleeding and/or hypotension;Secondary Objective: To evaluate the effect of Ilomedin® administration on endothelial activation/necrosis and platelet activation and aggregation after PCI ;Primary end point(s): •Bleeding complications as evaluated by TIMI and GUSTO criteria during the 24 hour Ilomedin® infusion. •Adverse events(death, stent thrombosis, need for urgent revascularization) | — |
Countries
Denmark
Outcome results
None listed