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

Primary Purpose

Myocardial Infarct

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Ilomedin

Placebo

Ilomedin

Ilomedin and standard low dose treatment

About this trial

This is an interventional treatment trial for Myocardial Infarct focused on measuring ST-eleveation, Myocardial infarct, Percutaneous coronary intervention, Myocardial infarct STEMI patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
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

Sites / Locations

Lene Holmvang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ilomedin and standard low dose treatment

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Bleeding complications as evaluated by TIMI and GUSTO criteria

Increased bleeding complications will be evaluated between the active and placebo groups.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01179776

First Posted

August 10, 2010

Last Updated

June 1, 2011

Sponsor

Thrombologic ApS

Collaborators

Lene Holmvang, Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01179776

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Thrombologic ApS

Collaborators

Lene Holmvang, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarct

Keywords

ST-eleveation, Myocardial infarct, Percutaneous coronary intervention, Myocardial infarct STEMI patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ilomedin and standard low dose treatment

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ilomedin

Other Intervention Name(s)

Iloprost

Intervention Description

Ilomedin

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

i.v saline

Intervention Type

Drug

Intervention Name(s)

Ilomedin

Intervention Type

Drug

Intervention Name(s)

Ilomedin and standard low dose treatment

Primary Outcome Measure Information:

Title

Bleeding complications as evaluated by TIMI and GUSTO criteria

Description

Increased bleeding complications will be evaluated between the active and placebo groups.

Time Frame

Feb 2011

Secondary Outcome Measure Information:

Title

Endothelial markers and blood aggregation (measured by TEG and multiplate)

Description

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.

Time Frame

Feb 2011

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lene Holmvang, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lene Holmvang

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

22951358

Citation

Holmvang L, Ostrowski SR, Dridi NP, Johansson P. A single center, open, randomized study investigating the clinical safety and the endothelial modulating effects of a prostacyclin analog in combination with eptifibatide in patients having undergone primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction. Prostaglandins Other Lipid Mediat. 2012 Dec;99(3-4):87-95. doi: 10.1016/j.prostaglandins.2012.08.002. Epub 2012 Aug 28.

Results Reference

derived

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

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