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

Thrombologic

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myocardial Infarct

Treatments

Drug: Ilomedin

Drug: Ilomedin and standard low dose treatment

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01179776

THR-PS-02

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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