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Colchicine in ST-elevation Myocardial Infarction

Study of Anti-inflammatory Treatment With Colchicine in the Acute Phase of ST-elevation Myocardial Infarction to Reduce Infarct Size

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01936285
Enrollment
150
Registered
2013-09-06
Start date
2013-07-31
Completion date
Unknown
Last updated
2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Brief 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

Interventions

DRUGColchicine 2 mg loading dose; 0.5 mg bid for 5 days
DRUGPlacebo

Sponsors

G.Gennimatas General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Infarct size on MRI5 days post-MIMRI with LGE will be performed in a subset of study participants
AUC CK-MB concentration0-3 days post-MIArea under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits

Secondary

MeasureTime frameDescription
Myocardial damage marker levelsDays 1-3 post-MIMaximal concentrations of hs-TnT and CK-MB

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026