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

June 1, 2011 updated by: Thrombologic ApS

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Lene Holmvang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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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

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
i.v saline
EXPERIMENTAL: Ilomedin and standard low dose treatment
Drug: Ilomedin
Ilomedin
Other Names:
  • Iloprost
Drug: Ilomedin
Drug: Ilomedin and standard low dose treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding complications as evaluated by TIMI and GUSTO criteria
Time Frame: Feb 2011
Increased bleeding complications will be evaluated between the active and placebo groups.
Feb 2011

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial markers and blood aggregation (measured by TEG and multiplate)
Time Frame: 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.
Feb 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thrombologic ApS

Collaborators

Rigshospitalet, Denmark
Lene Holmvang

Investigators

  • Principal Investigator: Lene Holmvang, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2011

Last Update Submitted That Met QC Criteria

June 1, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-PS-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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