Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

Study Overview
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Brief Summary
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Subsequent to the loss of myocardium post-myocardial infarction (MI), the affected ventricle undergoes some dynamic structural and functional changes known as remodeling. Cardiac remodeling progresses into heart failure (HF). In this revolutionized percutaneous coronary intervention (PCI) era, the incidence of post-MI HF due to cardiac remodeling remains high. Current standard therapeutic interventions, for HF, aimed solely at correcting a low cardiac output do not necessarily impede HF progression. Recently, doxycycline was found to have an additional biological effect aside from their antimicrobial actions. From several experimental studies and clinical trials, doxycycline showed MMP inhibition activities that can prevent ventricular remodeling. This study aims to evaluate the role of doxycycline in cardiac remodeling prevention post-MI. Our hypothesis is that a better heart function will be observed in STEMI patients who receive a short period of doxycycline administration post-PCI.

Official Title
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Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)

Conditions
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ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction, Heart Failure, Remodeling, Ventricular

Intervention / Treatment
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* Drug: Doxycycline 100Mg Capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Onset of STEMI <12 hours Anterior wall STEMI or Killip grade II-III or LVEF <50% Undergoing primary PCI Exclusion Criteria: Signs of infection (clinical judgement plus leukocyte count >15,000) STEMI mechanical complication Moderate-severe valvular disease Allergic to doxycycline Refuse to join the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm receives standard care after primary PCI, the other receives doxycycline b.i.d for 7 days as an adjunct to standard care
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycycline<br>Doxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI | Drug: Doxycycline 100Mg Capsule<br>* Doxycycline capsule<br>* Other names: Doxylin;|
| Placebo Comparator: Placebo<br>Placebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI | Drug: Placebo oral capsule<br>* Capsule manufactured to mimic doxycycline 100 mg capsule<br>* Other names: Placebo (for Doxycycline);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high sensitivity-Troponin T | hs-Troponin T in ng/L | 12 hours | 
| high sensitivity-CRP | hs-CRP in mg/L | 24 hours | 
| NT-pro BNP | NT-pro BNP in pg/ml | 5 days | 
| netrophils | absolute amount per micro liters | 24 hours | 
| ST2 | ST2 in ng/ml | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | The number of deceased participants | 4 months | 
| Heart failure incidence | Evaluating the occurrence of heart failure signs and/or symptoms | 4 months | 
| Re-hospitalization rate | The number of patients re-admitted due to heart failure signs and/or symptoms | 4 months | 
| Left ventricle function and dimension | Assessed through echocardiography | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Doxycycline, Cardiac Remodelling, STEMI