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Colchicine in ST-elevation Myocardial Infarction

Information source: G.Gennimatas General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myocardial Infarction

Intervention: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: G.Gennimatas General Hospital

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

Clinical Details

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

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

Primary outcome:

Infarct size on MRI

AUC CK-MB concentration

Secondary outcome: Myocardial damage marker levels

Eligibility

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Both.

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)

Locations and Contacts

Athens General Hospital "G. Gennimatas", Athens 11527, Greece; Recruiting
Spyridon Deftereos, MD, Phone: +302107768560, Email: spdeftereos@gmail.com
Spyridon Deftereos, MD, Principal Investigator
Christos Angelidis, MD, Sub-Investigator
Georgios Giannopoulos, MD, Sub-Investigator
Additional Information

Starting date: July 2013
Last updated: April 22, 2015

Page last updated: August 20, 2015

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