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Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Doxycycline 100Mg Capsule
Placebo oral capsule
Sponsored by
Felix Chikita Fredy, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Doxycycline, Cardiac Remodelling, STEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cardiovascular Center Harapan Kita HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Doxycycline

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

high sensitivity-Troponin T
hs-Troponin T in ng/L
high sensitivity-CRP
hs-CRP in mg/L
NT-pro BNP
NT-pro BNP in pg/ml
netrophils
absolute amount per micro liters
ST2
ST2 in ng/ml

Secondary Outcome Measures

Mortality rate
The number of deceased participants
Heart failure incidence
Evaluating the occurrence of heart failure signs and/or symptoms
Re-hospitalization rate
The number of patients re-admitted due to heart failure signs and/or symptoms
Left ventricle function and dimension
Assessed through echocardiography

Full Information

First Posted
May 16, 2019
Last Updated
August 5, 2019
Sponsor
Felix Chikita Fredy, MD
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT03960411
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2019 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Felix Chikita Fredy, MD
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction, Heart Failure, Remodeling, Ventricular
Keywords
Doxycycline, Cardiac Remodelling, STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The only party who is not masked is the pharmacist
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
Doxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI
Intervention Type
Drug
Intervention Name(s)
Doxycycline 100Mg Capsule
Other Intervention Name(s)
Doryx, Doxyhexal, Doxylin
Intervention Description
Doxycycline capsule
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo (for Doxycycline)
Intervention Description
Capsule manufactured to mimic doxycycline 100 mg capsule
Primary Outcome Measure Information:
Title
high sensitivity-Troponin T
Description
hs-Troponin T in ng/L
Time Frame
12 hours
Title
high sensitivity-CRP
Description
hs-CRP in mg/L
Time Frame
24 hours
Title
NT-pro BNP
Description
NT-pro BNP in pg/ml
Time Frame
5 days
Title
netrophils
Description
absolute amount per micro liters
Time Frame
24 hours
Title
ST2
Description
ST2 in ng/ml
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Mortality rate
Description
The number of deceased participants
Time Frame
4 months
Title
Heart failure incidence
Description
Evaluating the occurrence of heart failure signs and/or symptoms
Time Frame
4 months
Title
Re-hospitalization rate
Description
The number of patients re-admitted due to heart failure signs and/or symptoms
Time Frame
4 months
Title
Left ventricle function and dimension
Description
Assessed through echocardiography
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bambang Widyantoro, PhD
Phone
+62 812 8164299
Email
bambang_ui@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Felix C Fredy, MD
Phone
+62 821 12099811
Email
felixchikita@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bambang Widyantoro, PhD
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiovascular Center Harapan Kita Hospital
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bambang Widyantoro, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bambang Widyantoro, MD, PhD
First Name & Middle Initial & Last Name & Degree
Felix C Fredy, MD
First Name & Middle Initial & Last Name & Degree
Arief A Subakti, MD
First Name & Middle Initial & Last Name & Degree
Anindita Suputri, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24104875
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.
Results Reference
background
Links:
URL
http://academic.oup.com/eurheartj/article/35/3/184/492844
Description
TIPTOP Trial

Learn more about this trial

Effect of Doxycycline on Cardiac Remodelling in STEMI Patients

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