Clinical trial NCT01179776: Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarct
Keywords: ST-eleveation
Myocardial infarct
Percutaneous coronary intervention
Myocardial infarct STEMI patients
Lead sponsor: Thrombologic ApS
Sponsor class: INDUSTRY
Collaborators: name: Lene Holmvang
name: Rigshospitalet, Denmark
First posted: 2010-08-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. 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.

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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

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Primary outcomes:
measure: Bleeding complications as evaluated by TIMI and GUSTO criteria
timeFrame: Feb 2011
Secondary outcomes:
measure: Endothelial markers and blood aggregation (measured by TEG and multiplate)
timeFrame: Feb 2011
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lene Holmvang
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Holmvang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmvang L, Ostrowski SR, Dridi NP, Johansson P. A single center, open, randomized study investigating the clinical safety and the endothelial modulating effects of a prostacyclin analog in combination with eptifibatide in patients having undergone primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction. Prostaglandins Other Lipid Mediat. 2012 Dec;99(3-4):87-95. doi: 10.1016/j.prostaglandins.2012.08.002. Epub 2012 Aug 28.