Status:
COMPLETED
Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)
Lead Sponsor:
Thrombologic ApS
Collaborating Sponsors:
Lene Holmvang
Rigshospitalet, Denmark
Conditions:
Myocardial Infarct
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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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Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01179776
Start Date
September 1 2010
End Date
June 1 2011
Last Update
June 2 2011
Active Locations (1)
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1
Lene Holmvang
Copenhagen, Denmark, 2100