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)

Thrombologic ApS1 site in 1 country16 target enrollmentSeptember 2010

ConditionsMyocardial Infarct

InterventionsIlomedin Ilomedin and standard low dose treatment Placebo

DrugsIlomedin Placebo Ilomedin and standard low dose treatment

Overview

Phase: Phase 1
Intervention: Ilomedin
Conditions: Myocardial Infarct
Sponsor: Thrombologic ApS
Enrollment: 16
Locations: 1
Primary Endpoint: Bleeding complications as evaluated by TIMI and GUSTO criteria
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

June 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Thrombologic ApS

Eligibility Criteria

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.

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