The Effect of Colchicine on Inflammation in ACS Patients

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-05-20

Brief Summary

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This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients

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Detailed Description

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This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.

Conditions

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Acute Coronary Syndrome STEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation

Study Groups

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Colchicine group

Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months

Group Type EXPERIMENTAL

Colchicine Tablets

Intervention Type DRUG

Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months

STEMI standard treatment group

Control group, STEMI standard treatment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colchicine Tablets

Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months

Intervention Type DRUG

Other Intervention Names

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Colchicine

Eligibility Criteria

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Inclusion Criteria

* male or female
* \>18 yrs
* STEMI patients who were successfully treated with PCI.

Exclusion Criteria

* Pregnant or breast-feeding women or women of childbearing potential.
* Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
* Known hypersensitivity to colchicine or current chronic treatment with colchicine.
* Severe renal failure (estimated creatinine clearance \<30ml/min) or hepatic failure (Child Pugh score B or C )
* Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
* Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No