Acute Myocardial InfarctionPhase 2COLINNCT02363725
Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
A Phase 2 study testing Colchimax® and Conventional treatment in people with Acute Myocardial Infarction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background: Colchicine is an old well-known venerable drug routinely used in gout attacks for instance. More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Colchimax® and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Aug 2016
- Phase
- Phase 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial inflarction (occlusion of coronary artery as assessed on the coronaro angiogram)
- Adult (18-90y)
- Men / women
- Aigned informed consent
- Health insurance
Who cannot join
- Cardiogenic shock
- Digestive troubles
- Active bowels inflammatory disease (Crhon, chronic, diarrhea...)
- Intolerance to the drug
- Renal insufficiency clearance < 30mL/min
- Immunosuppression, aplasia
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- Active infectious disease, active known neoplasia, chronic inflammatory disease
- Hypersensitivity, allergy to one of studies components
- Active liver disease
- Poor hemodynamic conditions
- Recent severe sepsis
- Chronic treatment with corticoids or no steroids antiinflammatory agents
- No possibility for informed consent
- Protected by the law
- Poor abservance
- History of toxicomania, suicice attempts
- Pregnacy, breeding, project of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.
More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital.
Endpoints:
- Main endpoint: AUC CRP during the initial hospital stay
- Secondary endpoints:
- Clinical: oucomes
- Imaging: ETT, MRI
- Biological: various biomarkers
Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine
- Conditions
- Acute Myocardial Infarction
- Being tested
- Colchimax®, Conventional treatment
- Keywords
- Acute myocardial infarction, Inflammation, CRP, Colchicine
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchimax®Drug
Conventional treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Conventionnal treatment | Other | Optimal conventional treatment used for patients admitted for STEMI (ESC guidelines 2012):
* Double anti-aggregation
* IEC (or sartan) at best tolerated dose
* Beta-blocker at best tolerated dose
* High dose statin (usually atorvastatin 80 mg daily)
* If ventricular dysfunction; inhibitor minérolcorticoïdes (the eplerenone more often)
* Any other treatment will be logged. Receives: Drug: Conventional treatment |
| Conventionnal + Colchimax® | Experimental | Optimal conventional treatment + Colchimax® Receives: Drug: Colchimax®; Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC CRP
Measured: 5 days
Secondary outcomes (9)
Drug tolerance
Clinical outcome
Measured: 1 year
hospitalization time
Clinical outcome
Measured: 1 year
CRP measurement
Intrahospital peak CPK (Biological outcome)
Measured: 1 year
CPK measurement
Size IDM (pic and kinetics) (Biological outcome)
Measured: 1 year
Troponin-hs measurement
Size IDM (pic and kinetics) (Biological outcome)
Measured: 1 year
Creatinine level
Biological outcome
Measured: Day of inclusion and one month after inclusion
measurement of left ventricular end-systolic volume
Remodeling ETT
Measured: Day of inclusion and one month after inclusion
measurement of left ventricular diastolic volume
Remodeling ETT
Measured: Day of inclusion and one month after inclusion
measurement remodeling
Remodeling ETT
Measured: One month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois ROUBILLE, MD, PhD, Principal investigator, University Hospital, Montpellier France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363725
- Sponsor's protocol ID
- 9439
- Acronym
- COLIN
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2015
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
- ClinicalTrials.gov ID
- NCT02363725
- Acronym / sponsor ID
- COLIN / 9439
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Inflammation, CRP, Colchicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Feb 2015 (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.
Background:
Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.
More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital.
Endpoints:
- Main endpoint: AUC CRP during the initial hospital stay
- Secondary endpoints:
- Clinical: oucomes
- Imaging: ETT, MRI
- Biological: various biomarkers
Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventionnal treatment | Other | Drug: Conventional treatmentOptimal conventional treatment used for patients admitted for STEMI (ESC guidelines 2012): * Double anti-aggregation * IEC (or sartan) at best tolerated dose * Beta-blocker at best tolerated dose * High dose statin (usually atorvastatin 80 mg daily) * If ventricular dysfunction; inhibitor minérolcorticoïdes (the eplerenone more often) * Any other treatment will be logged. |
| Conventionnal + Colchimax® | Experimental | Drug: Colchimax®, Drug: Conventional treatmentOptimal conventional treatment + Colchimax® |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute myocardial inflarction (occlusion of coronary artery as assessed on the coronaro angiogram)
- Adult (18-90y)
- Men / women
- Aigned informed consent
- Health insurance
Key exclusion criteria (17 listed)
- Cardiogenic shock
- Digestive troubles
- Active bowels inflammatory disease (Crhon, chronic, diarrhea...)
- Intolerance to the drug
- Renal insufficiency clearance < 30mL/min
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 |
|---|---|---|
| Colchimax® | Drug | Conventionnal + Colchimax® |
| Conventional treatment | Drug | Conventionnal + Colchimax®, Conventionnal treatment |
Primary outcome
AUC CRP
Time frame: 5 days
9 secondary outcomes
Drug tolerance
Time frame: 1 year
hospitalization time
Time frame: 1 year
CRP measurement
Time frame: 1 year
CPK measurement
Time frame: 1 year
Troponin-hs measurement
Time frame: 1 year
Creatinine level
Time frame: Day of inclusion and one month after inclusion
measurement of left ventricular end-systolic volume
Time frame: Day of inclusion and one month after inclusion
measurement of left ventricular diastolic volume
Time frame: Day of inclusion and one month after inclusion
measurement remodeling
Time frame: One month after inclusion
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 18 Jan 2017.
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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.
Francois ROUBILLE, MD, PhD principal investigator
University Hospital, Montpellier France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchimax® and Conventional treatment in people with Acute Myocardial Infarction, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 17 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 18 Jan 2017. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
AUC CRP (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2017.