Effect of Doxycycline on Cardiac Remodelling in STEMI 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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-25

Study Completion Date

2019-11-30

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One arm receives standard care after primary PCI, the other receives doxycycline b.i.d for 7 days as an adjunct to standard care

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The only party who is not masked is the pharmacist

Study Groups

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Doxycycline

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

Group Type EXPERIMENTAL

Doxycycline 100Mg Capsule

Intervention Type DRUG

Doxycycline capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Capsule manufactured to mimic doxycycline 100 mg capsule

Interventions

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Doxycycline 100Mg Capsule

Doxycycline capsule

Intervention Type DRUG

Placebo oral capsule

Capsule manufactured to mimic doxycycline 100 mg capsule

Intervention Type DRUG

Other Intervention Names

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Doryx Doxyhexal Doxylin Placebo (for Doxycycline)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No