Acute Myocardial InfarctionPhase 4NCT01936285
Colchicine in ST-elevation Myocardial Infarction
A Phase 4 study testing Colchicine 2 mg loading dose; 0.5 mg bid for 5 days in people with Acute Myocardial Infarction, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial summary
There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2013to Apr 2015
- Phase
- Phase 4
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study will enroll patients 18 years old or older who present to the hospital within twelve (12) hours of the onset of chest pain and who had ST segment elevation >1 mm in two contiguous limb leads or ST segment elevation >2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.
- Excluded patients:
- > 80 years old
- with active inflammatory diseases, infectious diseases or known malignancy
- under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
- with known hypersensitivity-allergy to colchicine
Show all 17Show fewer
- under chronic treatment with colchicine
- with severe renal failure (eGFR < 30 ml/min/1.73 m2)
- with hepatic failure (Child - Pugh class B or C)
- presenting with cardiac arrest
- presenting with ventricular fibrillation
- presenting with cardiogenic shock
- with stent thrombosis
- with angina within 48 hours before infarction
- with previous myocardial infarction
- with occlusion of the left main or left circumflex coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
- with metallic implants (ferromagnetic material)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Athens General Hospital "G. Gennimatas"
Athens, 11527
Spyridon Deftereos, MD, +302107768560, spdeftereos@gmail.com
Spyridon Deftereos, MD
About this study
Official title: Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size
- There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction
- The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction
- Conditions
- Acute Myocardial Infarction
- Being tested
- Colchicine 2 mg loading dose; 0.5 mg bid for 5 days, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 2 mg loading dose; 0.5 mg bid for 5 daysDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients taking placebo Receives: Drug: Placebo |
| Colchicine | Experimental | Active treatment group Receives: Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size on MRI
MRI with LGE will be performed in a subset of study participants
Measured: 5 days post-MI
AUC CK-MB concentration
Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits
Measured: 0-3 days post-MI
Secondary outcomes (1)
Myocardial damage marker levels
Maximal concentrations of hs-TnT and CK-MB
Measured: Days 1-3 post-MI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015 (estimated)
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 Acute Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyridon Deftereos, G.Gennimatas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936285
- Sponsor's protocol ID
- COL.ACS
- Status last verified
- Apr 2015
- First submitted
- 2 Sep 2013
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deftereos S, Giannopoulos G, Angelidis C, Alexopoulos N, Filippatos G, Papoutsidakis N, Sianos G, Goudevenos J, Alexopoulos D, Pyrgakis V, Cleman MW, Manolis AS, Tousoulis D, Lekakis J. Anti-Inflammatory Treatment With Colchicine in Acute Myocardial Infarction: A Pilot Study. Circulation. 2015 Oct 13;132(15):1395-403. doi: 10.1161/CIRCULATIONAHA.115.017611. Epub 2015 Aug 11.
PubMed 26265659
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size
- ClinicalTrials.gov ID
- NCT01936285
- Acronym / sponsor ID
- COL.ACS
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (estimated)
- First posted
- 6 Sep 2013 (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.
- There is evidence that inflammatory processes may play detrimental role during the acute phase of myocardial infarction
- The hypothesis of this study is that colchicine, by its anti-inflammatory action, may lead to reduction in infarct size, when administered during the acute phase of myocardial infarction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboPatients taking placebo |
| Colchicine | Experimental | Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 daysActive treatment group |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- The study will enroll patients 18 years old or older who present to the hospital within twelve (12) hours of the onset of chest pain and who had ST segment elevation >1 mm in two contiguous limb leads or ST segment elevation >2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.
- > 80 years old
- with active inflammatory diseases, infectious diseases or known malignancy
- under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
- with known hypersensitivity-allergy to colchicine
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Colchicine 2 mg loading dose; 0.5 mg bid for 5 days | Drug | Colchicine |
| Placebo | Drug | Control group |
Primary outcome
Infarct size on MRI
Time frame: 5 days post-MI
MRI with LGE will be performed in a subset of study participants
AUC CK-MB concentration
Time frame: 0-3 days post-MI
Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits
1 secondary outcome
Myocardial damage marker levels
Time frame: Days 1-3 post-MI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Derived from this study: PubMed 26265659Deftereos S, Giannopoulos G, Angelidis C, Alexopoulos N, Filippatos G, Papoutsidakis N, Sianos G, Goudevenos J, Alexopoulos D, Pyrgakis V, Cleman MW, Manolis AS, Tousoulis D, Lekakis J. Anti-Inflammatory Treatment With Colchicine in Acute Myocardial Infarction: A Pilot Study. Circulation. 2015 Oct 13;132(15):1395-403. doi: 10.1161/CIRCULATIONAHA.115.017611. Epub 2015 Aug 11.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 2 mg loading dose; 0.5 mg bid for 5 days in people with Acute Myocardial Infarction, run by G.Gennimatas General Hospital at 1 site in Greece.
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 17 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Apr 2015. 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 Greece. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size on MRI (time frame: 5 days post-MI). The study lists 2 primary outcomes in all. 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 NCT01936285, 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 23 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.