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| Name | Class |
|---|---|
| Lene Holmvang | UNKNOWN |
| Rigshospitalet, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ilomedin and standard low dose treatment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilomedin | Drug | Ilomedin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding complications as evaluated by TIMI and GUSTO criteria | Increased bleeding complications will be evaluated between the active and placebo groups. | Feb 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial markers and blood aggregation (measured by TEG and multiplate) | 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. | Feb 2011 |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Lene Holmvang, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lene Holmvang | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22951358 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Placebo | Drug | i.v saline |
|
| Ilomedin | Drug |
|
| Ilomedin and standard low dose treatment | Drug |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |