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

Phase 1

Completed

• Conditions: Myocardial Infarct
• Interventions: Drug: Placebo; Drug: Ilomedin; Drug: Ilomedin and standard low dose treatment

• Registration Number: NCT01179776
• Lead Sponsor: Thrombologic ApS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Study Start: 2010-09
• Primary Completion: 2011-05
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ilomedin and standard low dose treatment	Ilomedin	-
Ilomedin and standard low dose treatment	Ilomedin and standard low dose treatment	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lene Holmvang; 🇩🇰 Copenhagen, Denmark