Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

NCT03960411 | Unknown Phase 3 DMC

• 1 other identifier: 01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Doxycycline; Cardiac Remodelling; STEMI

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Mortality rate

  4 months

• Heart failure incidence

  4 months

• Re-hospitalization rate

  4 months

• Left ventricle function and dimension

  4 months

Study Arms (2)

Doxycycline

EXPERIMENTAL

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

Drug: Doxycycline 100Mg Capsule

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

Doxycycline 100Mg Capsule DRUG

Doxycycline capsule

Also known as: Doryx, Doxyhexal, Doxylin

Doxycycline

Placebo oral capsule DRUG

Capsule manufactured to mimic doxycycline 100 mg capsule

Also known as: Placebo (for Doxycycline)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset of STEMI \<12 hours
• Anterior wall STEMI or Killip grade II-III or LVEF \<50%
• Undergoing primary PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Felix Chikita Fredy, MD: lead
• National Cardiovascular Center Harapan Kita Hospital Indonesia: collaborator

Study Sites (1)

National Cardiovascular Center Harapan Kita Hospital

Jakarta, 11420, Indonesia

RECRUITING

Related Publications (1)

• 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.

  PMID: 24104875 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Bambang Widyantoro, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bambang Widyantoro, PhD

CONTACT

+62 812 8164299; bambang_ui@yahoo.com

Felix C Fredy, MD

CONTACT

+62 821 12099811; felixchikita@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only party who is not masked is the pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: cardiology resident

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

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 23, 2019
• Study Start: May 25, 2019
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

ID (1)