Clinical trial NCT03960411: Effect of Doxycycline on Cardiac Remodelling in STEMI Patients
Official title: Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ST Elevation Myocardial Infarction
Anterior Wall Myocardial Infarction
Heart Failure
Remodeling, Ventricular
Keywords: Doxycycline
Cardiac Remodelling
STEMI
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: National Cardiovascular Center Harapan Kita Hospital Indonesia
First posted: 2019-05-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: high sensitivity-Troponin T
timeFrame: 12 hours
measure: high sensitivity-CRP
timeFrame: 24 hours
measure: NT-pro BNP
timeFrame: 5 days
measure: netrophils
timeFrame: 24 hours
measure: ST2
timeFrame: 24 hours
Secondary outcomes:
measure: Mortality rate
timeFrame: 4 months
measure: Heart failure incidence
timeFrame: 4 months
measure: Re-hospitalization rate
timeFrame: 4 months
measure: Left ventricle function and dimension
timeFrame: 4 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita Hospital
Study officials:
affiliation: Indonesia University
name: Bambang Widyantoro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cerisano G, Buonamici P, Valenti R, Sciagra R, Raspanti S, Santini A, Carrabba N, Dovellini EV, Romito R, Pupi A, Colonna P, Antoniucci D. Early short-term doxycycline therapy in patients with acute myocardial infarction and left ventricular dysfunction to prevent the ominous progression to adverse remodelling: the TIPTOP trial. Eur Heart J. 2014 Jan;35(3):184-91. doi: 10.1093/eurheartj/eht420. Epub 2013 Oct 8.