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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Myocardial Infarct

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ilomedin and standard low dose treatment

Group Type EXPERIMENTAL

Ilomedin

Intervention Type DRUG

Ilomedin

Intervention Type DRUG

Ilomedin and standard low dose treatment

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

i.v saline

Interventions

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Ilomedin

Intervention Type DRUG

Placebo

i.v saline

Intervention Type DRUG

Ilomedin

Intervention Type DRUG

Ilomedin and standard low dose treatment

Intervention Type DRUG

Other Intervention Names

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Iloprost

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No