Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)
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)
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 2, 2011
June 1, 2011
8 months
August 10, 2010
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding complications as evaluated by TIMI and GUSTO criteria
Increased bleeding complications will be evaluated between the active and placebo groups.
Feb 2011
Secondary Outcomes (1)
Endothelial markers and blood aggregation (measured by TEG and multiplate)
Feb 2011
Study Arms (2)
Ilomedin and standard low dose treatment
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thrombologic ApSlead
- Lene Holmvangcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (1)
Lene Holmvang
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 22951358DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Holmvang, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 11, 2010
Study Start
September 1, 2010
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
June 2, 2011
Record last verified: 2011-06