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OpenTrials
Completed

NCT Number: NCT01179776

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

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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Key information

Conditions

Myocardial Infarct Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lene Holmvang

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Undergoing primary PCI due to STEMI (TIMI flow I -III before PCI and symptom duration < 12 hours)
  • 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

  • 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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Treatment and study plan

Ilomedin

Drug

Ilomedin

Other names: Iloprost

Placebo

Drug

i.v saline

Ilomedin and standard low dose treatment

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Thrombologic ApS

Industry

Collaborators

  • Lene Holmvang
  • Rigshospitalet, Denmark

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2010
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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