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

This study has been completed.
Sponsor:
Collaborators:
Lene Holmvang
Rigshospitalet, Denmark
Information provided by:
Thrombologic ApS
ClinicalTrials.gov Identifier:
NCT01179776
First received: August 10, 2010
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Myocardial Infarct
Drug: Ilomedin
Drug: Placebo
Drug: Ilomedin and standard low dose treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Thrombologic ApS:

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


Secondary Outcome Measures:
  • Endothelial markers and blood aggregation (measured by TEG and multiplate) [ Time Frame: Feb 2011 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 16
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Thrombologic ApS

Additional 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
Study First Received: August 10, 2010
Last Updated: June 1, 2011
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on July 28, 2014