Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Colchicine Active treatment group
Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
Colchicine
Control group
Drug: Placebo
No interventions assigned to this group
Interventions
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Colchicine
Eligibility Criteria
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Inclusion Criteria
* Who presented to the hospital within twelve (12) hours of the onset of chest pain -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.
Exclusion Criteria
* with age \> 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)
* presented with cardiac arrest
* presented with ventricular fibrillation
* presented with cardiogenic shock
* with stent thrombosis
* with angina within 48 hours before infarction
* with previous myocardial infarction in the affected territory
* with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
18 Years
80 Years
ALL
No
Sponsors
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Academy of Athens
OTHER
G.Gennimatas General Hospital
OTHER
Responsible Party
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Spyridon Deftereos
Director, Cardiac Catheterization Department
Principal Investigators
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Constantinos Anagnostopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research Foundation of Academy of Athens
Christos Angelidis, MD
Role: PRINCIPAL_INVESTIGATOR
Athens General Hospital "G. Gennimatas"
Locations
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Athens General Hospital "G. Gennimatas"
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22977 / 29-08-2014
Identifier Type: -
Identifier Source: org_study_id
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