Colchicine in ST-elevation Myocardial Infarction

G.Gennimatas General Hospital

Status and phase

Unknown

Phase 4

Conditions

Acute Myocardial Infarction

Treatments

Drug: Placebo

Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days

Study type

Interventional

Funder types

Other

Identifiers

NCT01936285

COL.ACS

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)