Colchicine in ST-elevation Myocardial Infarction

NCT01936285 | Unknown Phase 4 DMC

• 1 other identifier: COL.ACS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Infarct size on MRI

  MRI with LGE will be performed in a subset of study participants

  5 days post-MI

• 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

Secondary Outcomes (1)

• Myocardial damage marker levels

  Days 1-3 post-MI

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients taking placebo

Drug: Placebo

Colchicine

EXPERIMENTAL

Active treatment group

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

Interventions

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

Colchicine

Placebo DRUG

Control group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead

Study Sites (1)

Athens General Hospital "G. Gennimatas"

Athens, 11527, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 26265659 DERIVED

MeSH Terms

Interventions

Colchicine; BID protein, human

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Department

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 6, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

GR (1)