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

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ClinicalTrials.gov Identifier: NCT01179776
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : June 2, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarct Drug: Ilomedin Drug: Placebo Drug: Ilomedin and standard low dose treatment Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ilomedin and standard low dose treatment Drug: Ilomedin
Ilomedin
Other Name: Iloprost
Drug: Ilomedin Drug: Ilomedin and standard low dose treatment
Placebo Comparator: Placebo Drug: Placebo
i.v saline


Outcome Measures

Primary Outcome Measures :
  1. Bleeding complications as evaluated by TIMI and GUSTO criteria [ Time Frame: Feb 2011 ]
    Increased bleeding complications will be evaluated between the active and placebo groups.


Secondary Outcome Measures :
  1. Endothelial markers and blood aggregation (measured by TEG and multiplate) [ Time Frame: Feb 2011 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179776


Locations
Denmark
Lene Holmvang
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Thrombologic ApS
Lene Holmvang
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lene Holmvang, MD Rigshospitalet, Denmark
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lene Holmvang, Rigshospitalet
ClinicalTrials.gov Identifier: NCT01179776     History of Changes
Other Study ID Numbers: THR-PS-02
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Keywords provided by Thrombologic ApS:
ST-eleveation
Myocardial infarct
Percutaneous coronary intervention
Myocardial infarct STEMI patients

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases