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

Myocardial Infarct Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179776
• Other study ID #: THR-PS-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 10, 2010
• Last updated: June 1, 2011
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Thrombologic ApS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarct
• Myocardial Infarction

Intervention

Drug:
• Ilomedin
Ilomedin
• Placebo
i.v saline
• Ilomedin

• Ilomedin and standard low dose treatment

Locations

Country	Name	City	State
Denmark	Lene Holmvang	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Thrombologic ApS	Lene Holmvang, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding complications as evaluated by TIMI and GUSTO criteria	Increased bleeding complications will be evaluated between the active and placebo groups.	Feb 2011	Yes
Secondary	Endothelial markers and blood aggregation (measured by TEG and multiplate)	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.	Feb 2011	Yes