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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03960411
Other study ID # 01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 25, 2019
Est. completion date November 2019

Study information

Verified date August 2019
Source Indonesia University
Contact Bambang Widyantoro, PhD
Phone +62 812 8164299
Email bambang_ui@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Doxycycline 100Mg Capsule
Doxycycline capsule
Placebo oral capsule
Capsule manufactured to mimic doxycycline 100 mg capsule

Locations

Country Name City State
Indonesia National Cardiovascular Center Harapan Kita Hospital Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Felix Chikita Fredy, MD National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

Cerisano G, Buonamici P, Valenti R, Sciagrà 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary high sensitivity-Troponin T hs-Troponin T in ng/L 12 hours
Primary high sensitivity-CRP hs-CRP in mg/L 24 hours
Primary NT-pro BNP NT-pro BNP in pg/ml 5 days
Primary netrophils absolute amount per micro liters 24 hours
Primary ST2 ST2 in ng/ml 24 hours
Secondary Mortality rate The number of deceased participants 4 months
Secondary Heart failure incidence Evaluating the occurrence of heart failure signs and/or symptoms 4 months
Secondary Re-hospitalization rate The number of patients re-admitted due to heart failure signs and/or symptoms 4 months
Secondary Left ventricle function and dimension Assessed through echocardiography 4 months
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