Myocardial InfarctPhase 1/2NCT01179776
Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)
A Phase 1/2 study testing Ilomedin and Ilomedin and standard low dose treatment in people with Myocardial Infarct, run by Thrombologic ApS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarct
- What is being tested?
- Ilomedin and Ilomedin and standard low dose treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Myocardial Infarct
- Being tested
- Ilomedin, Placebo, Ilomedin and standard low dose treatment
- Keywords
- ST-eleveation, Myocardial infarct, Percutaneous coronary intervention, Myocardial infarct STEMI patients
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlomedinDrug
Also called Iloprost
Ilomedin
PlaceboDrug
i.v saline
IlomedinDrug
Ilomedin and standard low dose treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Ilomedin and standard low dose treatment | Experimental | Not described Receives: Drug: Ilomedin; Drug: Ilomedin and standard low dose treatment |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding complications as evaluated by TIMI and GUSTO criteria
Increased bleeding complications will be evaluated between the active and placebo groups.
Measured: Feb 2011
Secondary outcomes (1)
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.
Measured: Feb 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thrombologic ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lene Holmvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Holmvang, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179776
- Sponsor's protocol ID
- THR-PS-02
- Status last verified
- Jun 2011
- First submitted
- 10 Aug 2010
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22951358
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01179776
- Acronym / sponsor ID
- THR-PS-02
- Conditions
- Myocardial Infarct
- Keywords
- ST-eleveation, Myocardial infarct, Percutaneous coronary intervention, Myocardial infarct STEMI patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Thrombologic ApSIndustry (pharma, biotech, devices)
- Collaborators
- Lene Holmvang, Copenhagen University Hospital, Rigshospitalet
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilomedin and standard low dose treatment | Experimental | Drug: Ilomedin, Drug: Ilomedin and standard low dose treatment |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IlomedinAlso: IloprostIlomedin | Drug | Ilomedin and standard low dose treatment |
| Placeboi.v saline | Drug | Placebo |
| Ilomedin | Drug | Ilomedin and standard low dose treatment |
| Ilomedin and standard low dose treatment | Drug | Ilomedin and standard low dose treatment |
Primary outcome
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.
1 secondary outcome
Endothelial markers and blood aggregation (measured by TEG and multiplate)
Time frame: Feb 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Derived from this study: PubMed 22951358Holmvang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Holmvang, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ilomedin and Ilomedin and standard low dose treatment in people with Myocardial Infarct, run by Thrombologic ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding complications as evaluated by TIMI and GUSTO criteria (time frame: Feb 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.