A Single center, open, randomized, placebo-controlled study investigating the safety of administration of Ilomedin® in addition to standard treatment in patients having undergone percutaneous coronary intervention (PCI) - Ilomedin® in patients undergoing PCI

Phase 1

• Conditions: Percutaneous coronary intervention (PCI) due to an acute ischemic event; MedDRA version: 12.1Level: LLTClassification code 10066642Term: Acute myocardial ischemia

• Registration Number: EUCTR2010-019920-30-DK
• Lead Sponsor: Rigshospitalet,Cardiology Laboratory 2013

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-01
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1)Age > 18 years
2)Undergoing primary PCI due to STEMI (TIMI flow 0-III before PCI and symptom duration < 12 hours)
3)Eligible for receiving platelet GPIIb/IIIa inhibitor (Integrillin®) therapy during and after PCI procedure as based on investigator judgement
4)Post-PCI treatment with Clopidogrel and ASA
5)No sign of significant or increased bleeding risk up to 18 hours following the PCI as evaluated by the treating physician
6)Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study data is used

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Known HIV positive
2)Not able to give informed consent
3)Women with childbearing potential
4)Concomitant treatment with K-vitamin antagonists (one bolus dose pre-PCI allowed)
5)Known congenital or acquired coagulopathy and/or thrombocytopathy
6)Heparin treatment except for dose given pre-PCI treatment
7)Received within 30 days prior to Day 1 prostacyclin or GPIIIB/IIA inhibitors
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 insuffience (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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of administration of Ilomedin® for 24 hours after PCI in addition to standard treatment with regard to development of bleeding and/or hypotension;Secondary Objective: To evaluate the effect of Ilomedin® administration on endothelial activation/necrosis and platelet activation and aggregation after PCI<br>;Primary end point(s): •Bleeding complications as evaluated by TIMI and GUSTO criteria during the 24 hour Ilomedin® infusion.<br>•Adverse events(death, stent thrombosis, need for urgent revascularization)<br>