Vascular DiseasesPhase 2/3MASTARDNCT02562651
Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI
A Phase 2/3 study testing Doxycycline in people with Vascular Diseases and Cardiovascular Diseases, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
- What is being tested?
- Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2014to Jun 2017
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)
- ST-elevation Q wave myocardial infarction
- term admission to an intensive care unit (ICU) in the first 24 hours of onset
- the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction
- written the informed consent to participate in research
Who cannot join
- atrial fibrillation, a permanent form
- valvular heart disease
- severe comorbidity
- acute heart failure according to the Killip classification IV FC (functional class)
- history of chronic heart failure (NYHA III-IV)
- poor image quality for Echocardiography
- sinus bradycardia - heart rate of under 50 beats per minute, interventricular conduction delay (QRS > 0,11 s.) and atrioventricular block II-III degree
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)
The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.
Read the detailed description
It is known that MMPs (matrix metalloproteinases) take part in myocardial remodeling, which lead to the adverse remodeling of left ventricular. Doxycycline inhibiting MMPs and it help to prevent collagen degradation and following LV (left ventricular) dilatation. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction by means of decrease in activity of MMPs-2 and recovery of contractile function of myocardium. The clinical trial was performed at 2013 (D.Antoniucci), but it was a single study and confirmed theoretical and experimental background.
The study is randomized, opened, controlled. 45 patients with the first anterior STEMI will be enrolled. On admission all patients will receive reperfusion therapy during the first 24 h. Patients will be randomized by the open envelope method and after that some of the participants will be on doxycycline (100 mg b.i.d. for 7 days) in addition to routine medical therapy for STEMI, but other will be on routine medical therapy of STEMI. After that they will have echocardiography at 3-d, 7-th, 14-th days and 6 month after STEMI. The investigators will evaluate left ventricular function of these patients by routine and speckle-tracking echocardiography, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, also the investigators will take blood samples to assess metalloproteinases (MMPs) and other biomarkers.
- Being tested
- Doxycycline, Standard care for STEMI
- Keywords
- STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline
- Medical subject headings
- Vascular Diseases, Cardiovascular Diseases, ST Elevation Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxycycline Solutab
Doxycycline bid for the first 7 days after primary anterior STEMI
Standard care for STEMIOther
Also called Invasive and medical treatment for STEMI
Invasive and medical treatment for STEMI according to guidelines
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | 100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy Receives: Drug: Doxycycline |
| Active comparator | Active comparator | Standard care for STEMI Receives: Other: Standard care for STEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in LV end-diastolic volumes index, %
Measured: 14 days and 6 month after STEMI
Secondary outcomes (9)
Incidence of cardiovascular death,%
Measured: 14 days and 6 month after STEMI
Incidence of the recurrent myocardial infarction,%
Measured: 14 days and 6 month after STEMI
Incidence of the angina,%
Measured: 14 days and 6 month after STEMI
Incidence of the heart failure,%
Measured: 14 days and 6 month after STEMI
Incidence of the stroke,%
Measured: 14 days and 6 month after STEMI
Incidence of the combined endpoint,%
Measured: 14 days and 6 month after STEMI
Incidence and severity of adverse events,%
Measured: 14 days and 6 month after STEMI
Changes in 2 D global longitudinals strain,Δ %
Measured: 14 days and 6 month after STEMI
Changes in MMPs and their inhibitors, other biomarkers, pg/ml
Measured: 14 days and 6 month after STEMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vyacheslav Ryabov, Russian Academy of Medical Sciences
- Investigators
- Vyacheslav Ryabov, MD,PhD, Principal investigator, Research Institute for Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562651
- Sponsor's protocol ID
- 1202
- Acronym
- MASTARD
- Status last verified
- Dec 2016
- First submitted
- 26 Jul 2015
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)
- ClinicalTrials.gov ID
- NCT02562651
- Acronym / sponsor ID
- MASTARD / 1202
- Keywords
- STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Sep 2015 (estimated)
- 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.
The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.
Detailed description
It is known that MMPs (matrix metalloproteinases) take part in myocardial remodeling, which lead to the adverse remodeling of left ventricular. Doxycycline inhibiting MMPs and it help to prevent collagen degradation and following LV (left ventricular) dilatation. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction by means of decrease in activity of MMPs-2 and recovery of contractile function of myocardium. The clinical trial was performed at 2013 (D.Antoniucci), but it was a single study and confirmed theoretical and experimental background.
The study is randomized, opened, controlled. 45 patients with the first anterior STEMI will be enrolled. On admission all patients will receive reperfusion therapy during the first 24 h. Patients will be randomized by the open envelope method and after that some of the participants will be on doxycycline (100 mg b.i.d. for 7 days) in addition to routine medical therapy for STEMI, but other will be on routine medical therapy of STEMI. After that they will have echocardiography at 3-d, 7-th, 14-th days and 6 month after STEMI. The investigators will evaluate left ventricular function of these patients by routine and speckle-tracking echocardiography, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, also the investigators will take blood samples to assess metalloproteinases (MMPs) and other biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: Doxycycline100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy |
| Active comparator | Active comparator | Other: Standard care for STEMIStandard care for STEMI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)
- ST-elevation Q wave myocardial infarction
- term admission to an intensive care unit (ICU) in the first 24 hours of onset
- the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction
- written the informed consent to participate in research
Key exclusion criteria (7 listed)
- atrial fibrillation, a permanent form
- valvular heart disease
- severe comorbidity
- acute heart failure according to the Killip classification IV FC (functional class)
- history of chronic heart failure (NYHA III-IV)
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 |
|---|---|---|
| DoxycyclineAlso: Doxycycline SolutabDoxycycline bid for the first 7 days after primary anterior STEMI | Drug | Doxycycline |
| Standard care for STEMIAlso: Invasive and medical treatment for STEMIInvasive and medical treatment for STEMI according to guidelines | Other | Active comparator |
Primary outcome
Changes in LV end-diastolic volumes index, %
Time frame: 14 days and 6 month after STEMI
9 secondary outcomes
Incidence of cardiovascular death,%
Time frame: 14 days and 6 month after STEMI
Incidence of the recurrent myocardial infarction,%
Time frame: 14 days and 6 month after STEMI
Incidence of the angina,%
Time frame: 14 days and 6 month after STEMI
Incidence of the heart failure,%
Time frame: 14 days and 6 month after STEMI
Incidence of the stroke,%
Time frame: 14 days and 6 month after STEMI
Incidence of the combined endpoint,%
Time frame: 14 days and 6 month after STEMI
Incidence and severity of adverse events,%
Time frame: 14 days and 6 month after STEMI
Changes in 2 D global longitudinals strain,Δ %
Time frame: 14 days and 6 month after STEMI
Changes in MMPs and their inhibitors, other biomarkers, pg/ml
Time frame: 14 days and 6 month after STEMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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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.
Vyacheslav Ryabov, MD,PhD principal investigator
Research Institute for Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Doxycycline in people with Vascular Diseases and Cardiovascular Diseases, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 5 inclusion and 7 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 13 Dec 2016. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in LV end-diastolic volumes index, % (time frame: 14 days and 6 month after STEMI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2016.