Colchicine in ST-elevation Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01936285
• Other study ID #: COL.ACS
• Status: Recruiting
• Phase: Phase 4
• First received: September 2, 2013
• Last updated: April 22, 2015
• Start date: July 2013

Study information

• Verified date: April 2015
• Source: G.Gennimatas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: National Organization of Medicines
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

• Placebo

Locations

Country	Name	City	State
Greece	Athens General Hospital "G. Gennimatas"	Athens

Sponsors (1)

Lead Sponsor	Collaborator
G.Gennimatas General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size on MRI	MRI with LGE will be performed in a subset of study participants	5 days post-MI	No
Primary	AUC CK-MB concentration	Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits	0-3 days post-MI	No
Secondary	Myocardial damage marker levels	Maximal concentrations of hs-TnT and CK-MB	Days 1-3 post-MI	No