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

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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01179776

Enrollment

Registered

2010-08-11

Start date

2010-09-30

Completion date

2011-06-30

Last updated

2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarct

Keywords

ST-eleveation, Myocardial infarct, Percutaneous coronary intervention, Myocardial infarct STEMI patients

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.

Interventions

DRUGIlomedin

Ilomedin

DRUGPlacebo

i.v saline

DRUGIlomedin and standard low dose treatment

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Bleeding complications as evaluated by TIMI and GUSTO criteria	Feb 2011	Increased bleeding complications will be evaluated between the active and placebo groups.

Secondary

Measure	Time frame	Description
Endothelial markers and blood aggregation (measured by TEG and multiplate)	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026