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Colchicine in ST-elevation Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Athens General Hospital "G. Gennimatas"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Colchicine

Arm Description

Patients taking placebo

Active treatment group

Outcomes

Primary Outcome Measures

Infarct size on MRI

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

AUC CK-MB concentration

Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits

Secondary Outcome Measures

Myocardial damage marker levels

Maximal concentrations of hs-TnT and CK-MB

Full Information

NCT ID

NCT01936285

First Posted

September 2, 2013

Last Updated

April 22, 2015

Sponsor

G.Gennimatas General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01936285

Brief Title

Colchicine in ST-elevation Myocardial Infarction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

G.Gennimatas General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Patients taking placebo

Arm Title

Colchicine

Arm Type

Experimental

Arm Description

Active treatment group

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Infarct size on MRI

Description

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

Time Frame

5 days post-MI

Title

AUC CK-MB concentration

Description

Area under the curve of creatine kinase-MB fraction concentrations from presentation to 72h will be assessed in all recruits

Time Frame

0-3 days post-MI

Secondary Outcome Measure Information:

Title

Myocardial damage marker levels

Description

Maximal concentrations of hs-TnT and CK-MB

Time Frame

Days 1-3 post-MI

10. Eligibility

Sex

All

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Athens General Hospital "G. Gennimatas"

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Spyridon Deftereos, MD

Phone

+302107768560

spdeftereos@gmail.com

First Name & Middle Initial & Last Name & Degree

Spyridon Deftereos, MD

First Name & Middle Initial & Last Name & Degree

Christos Angelidis, MD

First Name & Middle Initial & Last Name & Degree

Georgios Giannopoulos, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26265659

Citation

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.

Results Reference

derived

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Colchicine in ST-elevation Myocardial Infarction

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