Colchicine in ST-elevation Myocardial Infarction

Phase 4

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Placebo; Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days

• Registration Number: NCT01936285
• Lead Sponsor: G.Gennimatas General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-06
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	Patients taking placebo
Colchicine	Colchicine 2 mg loading dose; 0.5 mg bid for 5 days	Active treatment group

Primary Outcome Measures

Name	Time	Method
Infarct size on MRI	5 days post-MI	MRI with LGE will be performed in a subset of study participants
AUC CK-MB concentration	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

Secondary Outcome Measures

Name	Time	Method
Myocardial damage marker levels	Days 1-3 post-MI	Maximal concentrations of hs-TnT and CK-MB

Trial Locations

Locations (1)

Athens General Hospital "G. Gennimatas"; 🇬🇷 Athens, Greece