Trial | NCT01179776  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    iloprost ...

  • Study Participants

    16
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.
Study Started
Sep 30
2010
Primary Completion
May 31
2011
Study Completion
Jun 30
2011
Last Update
Jun 02
2011
Estimate

Drug Ilomedin

Ilomedin

  • Other names: Iloprost

Drug Placebo

i.v saline

Drug Ilomedin

Drug Ilomedin and standard low dose treatment

Ilomedin and standard low dose treatment Experimental

Placebo Placebo Comparator

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.

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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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No Results Posted