Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

Felix Chikita Fredy, MD

Status and phase: Unknown; Phase 3

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

Treatments: Drug: Doxycycline 100Mg Capsule; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03960411

01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Doxycycline

Experimental group

Description:

Doxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI

Treatment:

Drug: Doxycycline 100Mg Capsule

Placebo

Placebo Comparator group

Description:

Placebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI

Treatment:

Drug: Placebo oral capsule