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Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

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ClinicalTrials.gov Identifier: NCT03960411
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Information provided by (Responsible Party):
Felix Chikita Fredy, MD, Indonesia University

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.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Anterior Wall Myocardial Infarction Heart Failure Remodeling, Ventricular Drug: Doxycycline 100Mg Capsule Drug: Placebo oral capsule Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The only party who is not masked is the pharmacist
Primary Purpose: Treatment
Official Title: Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Doxycycline
Doxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI
Drug: Doxycycline 100Mg Capsule
Doxycycline capsule
Other Names:
  • Doryx
  • Doxyhexal
  • Doxylin

Placebo Comparator: Placebo
Placebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI
Drug: Placebo oral capsule
Capsule manufactured to mimic doxycycline 100 mg capsule
Other Name: Placebo (for Doxycycline)




Primary Outcome Measures :
  1. high sensitivity-Troponin T [ Time Frame: 12 hours ]
    hs-Troponin T in ng/L

  2. high sensitivity-CRP [ Time Frame: 24 hours ]
    hs-CRP in mg/L

  3. NT-pro BNP [ Time Frame: 5 days ]
    NT-pro BNP in pg/ml

  4. netrophils [ Time Frame: 24 hours ]
    absolute amount per micro liters

  5. ST2 [ Time Frame: 24 hours ]
    ST2 in ng/ml


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 4 months ]
    The number of deceased participants

  2. Heart failure incidence [ Time Frame: 4 months ]
    Evaluating the occurrence of heart failure signs and/or symptoms

  3. Re-hospitalization rate [ Time Frame: 4 months ]
    The number of patients re-admitted due to heart failure signs and/or symptoms

  4. Left ventricle function and dimension [ Time Frame: 4 months ]
    Assessed through echocardiography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960411


Contacts
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Contact: Bambang Widyantoro, PhD +62 812 8164299 bambang_ui@yahoo.com
Contact: Felix C Fredy, MD +62 821 12099811 felixchikita@gmail.com

Locations
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Indonesia
National Cardiovascular Center Harapan Kita Hospital Recruiting
Jakarta, Indonesia, 11420
Contact: Bambang Widyantoro, MD, PhD         
Principal Investigator: Bambang Widyantoro, MD, PhD         
Sub-Investigator: Felix C Fredy, MD         
Sub-Investigator: Arief A Subakti, MD         
Sub-Investigator: Anindita Suputri, MD         
Sponsors and Collaborators
Felix Chikita Fredy, MD
National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
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Principal Investigator: Bambang Widyantoro, PhD Indonesia University

Additional Information:
Publications:
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Responsible Party: Felix Chikita Fredy, MD, cardiology resident, Indonesia University
ClinicalTrials.gov Identifier: NCT03960411     History of Changes
Other Study ID Numbers: 01
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Felix Chikita Fredy, MD, Indonesia University:
Doxycycline
Cardiac Remodelling
STEMI
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Anterior Wall Myocardial Infarction
Infarction
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Pathological Conditions, Anatomical
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents