ST Elevation Myocardial InfarctionPhase 3NCT03960411
Effect of Doxycycline on Cardiac Remodelling in STEMI Patients
A Phase 3 study testing Doxycycline 100Mg Capsule in people with ST Elevation Myocardial Infarction and Anterior Wall Myocardial Infarction, run by Felix Chikita Fredy, MD at 1 site in Indonesia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction, Heart Failure
- What is being tested?
- Doxycycline 100Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 May 2019to Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Onset of STEMI <12 hours
- Anterior wall STEMI or Killip grade II-III or LVEF <50%
- Undergoing primary PCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
National Cardiovascular Center Harapan Kita Hospital
Jakarta, 11420
Bambang Widyantoro, MD, PhD
Bambang Widyantoro, MD, PhD
About this study
Official title: Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)
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
- Being tested
- Doxycycline 100Mg Capsule, Placebo oral capsule
- Keywords
- Doxycycline, Cardiac Remodelling, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction, Heart Failure, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline 100Mg CapsuleDrug
Also called Doryx, Doxyhexal, Doxylin
Doxycycline capsule
Placebo oral capsuleDrug
Also called Placebo (for Doxycycline)
Capsule manufactured to mimic doxycycline 100 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | Doxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI Receives: Drug: Doxycycline 100Mg Capsule |
| Placebo | Placebo comparator | Placebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
high sensitivity-Troponin T
hs-Troponin T in ng/L
Measured: 12 hours
high sensitivity-CRP
hs-CRP in mg/L
Measured: 24 hours
NT-pro BNP
NT-pro BNP in pg/ml
Measured: 5 days
netrophils
absolute amount per micro liters
Measured: 24 hours
ST2
ST2 in ng/ml
Measured: 24 hours
Secondary outcomes (4)
Mortality rate
The number of deceased participants
Measured: 4 months
Heart failure incidence
Evaluating the occurrence of heart failure signs and/or symptoms
Measured: 4 months
Re-hospitalization rate
The number of patients re-admitted due to heart failure signs and/or symptoms
Measured: 4 months
Left ventricle function and dimension
Assessed through echocardiography
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start25 May 2019
- Primary completionAug 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felix Chikita Fredy, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Responsible party
- Sponsor-investigator, Felix Chikita Fredy, MD, Universitas Indonesia
- Investigators
- Bambang Widyantoro, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960411
- Sponsor's protocol ID
- 01
- Status last verified
- Aug 2019
- First submitted
- 16 May 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24104875
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Doxycycline on Cardiac Remodelling in Patients With ST-Elevation Myocardial Infarction (STEMI)
- ClinicalTrials.gov ID
- NCT03960411
- Acronym / sponsor ID
- 01
- Conditions
- ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction, Heart Failure, Remodeling, Ventricular
- Keywords
- Doxycycline, Cardiac Remodelling, STEMI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Felix Chikita Fredy, MDUniversity, hospital or other
- Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Study start
- 25 May 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: Doxycycline 100Mg CapsuleDoxycycline 100 mg capsule by mouth every 12 hours for 7 days, administered early after primary PCI |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo capsule by mouth every 12 hours for 7 days, administered early after primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Onset of STEMI <12 hours
- Anterior wall STEMI or Killip grade II-III or LVEF <50%
- Undergoing primary PCI
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline 100Mg CapsuleAlso: Doryx, Doxyhexal, DoxylinDoxycycline capsule | Drug | Doxycycline |
| Placebo oral capsuleAlso: Placebo (for Doxycycline)Capsule manufactured to mimic doxycycline 100 mg capsule | Drug | Placebo |
Primary outcome
high sensitivity-Troponin T
Time frame: 12 hours
hs-Troponin T in ng/L
high sensitivity-CRP
Time frame: 24 hours
hs-CRP in mg/L
NT-pro BNP
Time frame: 5 days
NT-pro BNP in pg/ml
netrophils
Time frame: 24 hours
absolute amount per micro liters
ST2
Time frame: 24 hours
ST2 in ng/ml
4 secondary outcomes
Mortality rate
Time frame: 4 months
Heart failure incidence
Time frame: 4 months
Re-hospitalization rate
Time frame: 4 months
Left ventricle function and dimension
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Background: PubMed 24104875Cerisano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bambang Widyantoro, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycycline 100Mg Capsule in people with ST Elevation Myocardial Infarction and Anterior Wall Myocardial Infarction, run by Felix Chikita Fredy, MD at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bambang Widyantoro, PhD (+62 812 8164299, bambang_ui@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high sensitivity-Troponin T (time frame: 12 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.