Colchicine in ST-elevation Myocardial Infarction

NCT ID: NCT01936285

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31

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

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

Patients taking placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Colchicine

Active treatment group

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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)

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G.Gennimatas General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Spyridon Deftereos

Director, Cardiac Catheterization Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Athens General Hospital "G. Gennimatas"

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Spyridon Deftereos, MD

Role: primary

spdeftereos@gmail.com

+302107768560

References

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.

Reference Type: DERIVED

PMID: 26265659 (View on PubMed)

Other Identifiers

COL.ACS

Identifier Type: -

Identifier Source: org_study_id