Myocardial InfarctionPhase 4CONTRASTNCT02590653
Assessment of the Effects of Atorvastatin Therapy on Myocardial Deformation Characteristics, in Patients With STEMI
A Phase 4 study testing Atorvastatin in people with Myocardial Infarction, run by Penza State University at 1 site in Russia.
Trial summary
The primary goal To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment; The… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2014to Feb 2020
- Phase
- Phase 4
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Patients having physical and mental ability to participate in the study
- Patients of both sexes aged 35 to 65 years
- Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels.
- Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30%.
Who cannot join
- A history of repeat or recurrent myocardial infarction;
- A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA);
- Presence of left ventricular hypertrophy confirmed by echocardiography;
- QRS complex exceeding 1.0;
- Ejection fraction less than 40%;
- Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
Show all 22Show fewer
- Type 1 diabetes mellitus;
- Type 2 diabetes mellitus requiring pharmacotherapeutic correction with insulin;
- Any severe concurrent disease;
- A history of acute cerebrovascular accident (ACVA) within the 6 month period preceding the study;
- Active hepatic disease or liver enzyme elevation of unclear etiology more than 3 times higher than the upper limit of normal;
- Hepatic failure or bilirubin elevation more than 1.5 times higher than the upper limit of normal;
- Uncontrolled arterial hypertension (AH), with systolic blood pressure (SBP) exceeding 180 mm Hg and diastolic blood pressure (DBP) exceeding 110 mm Hg;
- A history of heart rhythm and/or cardiac conduction disorder;
- Inborn and/or acquired heart defects;
- A history of aortic aneurysm;
- Current existence of severe anemia (Hb < 100 g/L);
- Chronic renal disease (creatinine clearance < 30 mL/min);
- Uncorrected thyroid dysfunction, with hyper- or hypothyroidism;
- Intolerance of statins;
- Alcohol abuse and drug use;
- Participation in other clinical studies within the last two months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effects of Aggressive Atorvastatin Therapy on Myocardial Deformation Characteristics, Vascular Rigidity, 24 Hour ECG Monitoring Parameters and Quality of Life in Patients With STEMI
The primary goal
- To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment;
Read more
The secondary goals. To evaluate the effect of treatment:
- on the parameters of the global and regional myocardial deformation in the intact area on day 7, on 12, 24, 36 and 48 weeks of treatment;
- on the parameters of the global and regional myocardial deformation depending on the degree of coronary blood flow restoration by thrombolysis in myocardial infarction (TIMI)
- on systolic and diastolic left ventricular function in the presence of initial impairments, or absence of the negative dynamics of these parameters in case of normal baseline values;
- on the clinical diagnostic criteria for the development or progression of heart failure;
- the dynamics of the duration and extent of myocardial ischemia according to the daily ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;
- the appearance of new prognostically significant cardiac arrhythmias
- on the pulse wave velocity
- the thickness of the intima-media complex (IMT); 200 patients are planned to be include in a randomized, single-center, open, prospective, controlled clinical trial, the enrollment will be held at the Department of "Therapy" of Medical Institute of Penza State University.
Definition of the study group:
The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in the study
- Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;
- Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned number of patients: Pre-Screening - 300 subjects; screening and randomization - 200 subjects.
Patients will be randomized by random number generation to include in the group 1 or 2. All included patients will be on the standard basis therapy of the coronary artery disease, according to the national recommendation.
Read the detailed description
- Hypotheses:
- Atorvastatin therapy directly results in improved deformation characteristics of hibernating myocardium due to its pleiotropic effects on endothelial dysfunction and atherosclerotic plaque stability, as well as stimulation of angiogenesis in ischemic zones of myocardium.
- Long-term atorvastatin therapy improves the morphofunctional properties of large arteries and decreases the severity of endothelial dysfunction in patients with a history of myocardial infarction.
- Atorvastatin causes an anti-ischemic effect, if used for a long time. 2.1. Primary objective To evaluate the effect of atorvastatin, when started between 24 and 96 hours after disease onset, on the parameters of global and regional myocardial deformation in the zone of infarction, as well as morphofunctional properties of arteries, on Day 7 and Weeks 12, 24, 36 and 48 of the treatment; 2.2. Secondary objectives. To evaluate:
- the effect of treatment on the parameters of global and regional myocardial deformation in the zone of intact myocardium on Day 7 and Weeks 12, 24, 36 and 48 of the treatment;
- the effect of treatment on the parameters of global and regional myocardial deformation depending on TIMI blood flow grade;
- the effect of treatment on systolic and diastolic function of the left ventricle in patients with impaired left ventricular function at baseline, as well as the ability of this treatment to prevent deterioration of left ventricular function in patients with normal left ventricular function at baseline;
- the effect of treatment on heart failure development and progression as assessed using the corresponding clinical diagnostic criteria;
- the effect of treatment on duration and time course of myocardial ischemia using 24 hour ECG monitoring on Day 7 and Weeks 12, 24, 36 and 48 of treatment;
- the effect of treatment on the appearance of new prognostically significant disorders of cardiac rhythm;
- the effect of treatment on pulse wave velocity and cardio-ankle vascular index (CAVI);
- the effect of treatment on intima-media thickness (IMT);
- the effect of treatment on the results of automated quantitative vascular elasticity measurements, pulse wave and pulse pressure;
- the effect of treatment on endothelial function using the reactive hyperemia test;
- the effect of treatment on the time course of blood chemistry parameters (i.e., total cholesterol, HDL, LDL, triglycerides, creatinine, C-reactive protein (CRP), alanine transaminase (ALT), aspartate transaminase (AST) and creatinkinase (CK);
- the safety of treatment;
- the effect of treatment on patient's well-being and quality of life;
- patient compliance with the therapy. 2.3. Scientific novelty of the study It is planned to study, for the first time, the effect of long-term aggressive statin therapy on the functional status of myocardium in the zone of ischemia, lesion and necrosis in patients with STEMI using the two-dimensional strain procedure.
It is planned, for the first time, to comprehensively study the effect of aggressive statin therapy on the status of vasculature, with measuring multiple parameters characterizing the morphofunctional status of elastic and muscular arteries in patients with documented coronary heart disease (CHD).
2.4. Clinical significance of study results. If the proposed hypotheses are confirmed after the primary endpoints described in Section 3 have been reached, new convincing evidence supporting the use of long-term aggressive treatment with Atorvastatin starting from the early stages of myocardial infarction will be obtained. Obviously, the clinical benefits will include the improved prognosis and decreased risk of repeated vascular events. Favorable effects of this therapy on the morphofunctional status of arterial vasculature will play an important role in the treatment of these patients. Positive results of this study can form the basis for planning and conducting larger studies on pleiotropic effects of Atorvastatin in patients with a history of myocardial infarction.
- Primary endpoints
- Statistically significant differences in spatial and velocity parameters of myocardial deformation in the zone of previous STEMI as compared to controls.
- Statistically significant differences in spatial and velocity parameters of myocardial deformation in the intact zone after STEMI as compared to controls.
- Statistically significant differences in intima-media thickness (IMT) according to echo tracking data as compared to controls.
- Statistically significant differences in carotid-femoral pulse wave velocity and CAVI as compared to controls.
- Planning and conducting the study. It is planned to include 200 patients in this randomized, open-label, single-center, prospective, controlled clinical study; these patients will be recruited at the Department of Therapy of the Penza State University Medical Institute.
4.1. Allocation to study groups:
Patients with STEMI will be included in this study:
Group 1: 100 patients with STEMI to receive atorvastatin at a dose of 80 mg per day for 48 weeks; Group 2: 100 patients with STEMI to receive atorvastatin at a dose of 20 mg per day for 48 weeks.
4.2. Planned number of patients: Prescreening - 300 patients; screening and randomization - 200 patients.
4.3. Study design. Patients will be randomized using sealed envelopes numbered with increasing serial numbers from 1 to 200; each envelope will contain information about patient inclusion into Group 1 or Group 2. Information about treatment schedule and dosing regimen will be provided separately.
4.3.1. Treatment regimen, dose titration strategy and combination treatment principles Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study.
Group A patients will start the treatment between 24 and 96 hours after the onset of STEMI:
- Atorvastatin at a dose of 80 mg per day.
Group K patients will start the treatment between 24 and 96 hours after the onset of STEMI:
- Atorvastatin at a dose of 20 mg per day.
- Conditions
- Myocardial Infarction
- Being tested
- Atorvastatin
- Keywords
- STEMI, myocardial strain, atorvastatin
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Statin
Lipid-lowering therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A patients will start atorvastatin at a dose of 80 mg/day between 24 and 96 hours after the onset of STEMI Receives: Drug: Atorvastatin |
| Group K | Active comparator | Group K patients will start atorvastatin at a dose of 20 mg/day between 24 and 96 hours after the onset of STEMI Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Myocardial infarction, Unstable angina, Cardiac death
Measured: 2 years
Secondary outcomes (5)
Global myocardial strain in the zone of previous STEMI and in the intact zone after STEMI
two-dimensional strain
Measured: 2 years
Global myocardial strain rate in the zone of previous STEMI and in the intact zone after STEMI
two-dimensional strain
Measured: 2 years
Intima-media thickness of carotid artery
echo-tracking
Measured: 2 years
Carotid-femoral pulse wave velocity
Applanation tonometry
Measured: 2 years
Cardiac-ankle vascular index
Volume sphygmography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penza State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentin Oleynikov, prof., Principal investigator, Head of Therapy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590653
- Sponsor's protocol ID
- PSU/T-253
- Acronym
- CONTRAST
- Status last verified
- Mar 2020
- First submitted
- 22 Oct 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Aggressive Atorvastatin Therapy on Myocardial Deformation Characteristics, Vascular Rigidity, 24 Hour ECG Monitoring Parameters and Quality of Life in Patients With STEMI
- ClinicalTrials.gov ID
- NCT02590653
- Acronym / sponsor ID
- CONTRAST / PSU/T-253
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, myocardial strain, atorvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Penza State UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 29 Oct 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 primary goal
- To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment;
The secondary goals. To evaluate the effect of treatment:
- on the parameters of the global and regional myocardial deformation in the intact area on day 7, on 12, 24, 36 and 48 weeks of treatment;
- on the parameters of the global and regional myocardial deformation depending on the degree of coronary blood flow restoration by thrombolysis in myocardial infarction (TIMI)
- on systolic and diastolic left ventricular function in the presence of initial impairments, or absence of the negative dynamics of these parameters in case of normal baseline values;
- on the clinical diagnostic criteria for the development or progression of heart failure;
- the dynamics of the duration and extent of myocardial ischemia according to the daily ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;
- the appearance of new prognostically significant cardiac arrhythmias
- on the pulse wave velocity
- the thickness of the intima-media complex (IMT); 200 patients are planned to be include in a randomized, single-center, open, prospective, controlled clinical trial, the enrollment will be held at the Department of "Therapy" of Medical Institute of Penza State University.
Definition of the study group:
The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in the study
- Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;
- Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned number of patients: Pre-Screening - 300 subjects; screening and randomization - 200 subjects.
Patients will be randomized by random number generation to include in the group 1 or 2. All included patients will be on the standard basis therapy of the coronary artery disease, according to the national recommendation.
Detailed description
- Hypotheses:
- Atorvastatin therapy directly results in improved deformation characteristics of hibernating myocardium due to its pleiotropic effects on endothelial dysfunction and atherosclerotic plaque stability, as well as stimulation of angiogenesis in ischemic zones of myocardium.
- Long-term atorvastatin therapy improves the morphofunctional properties of large arteries and decreases the severity of endothelial dysfunction in patients with a history of myocardial infarction.
- Atorvastatin causes an anti-ischemic effect, if used for a long time. 2.1. Primary objective To evaluate the effect of atorvastatin, when started between 24 and 96 hours after disease onset, on the parameters of global and regional myocardial deformation in the zone of infarction, as well as morphofunctional properties of arteries, on Day 7 and Weeks 12, 24, 36 and 48 of the treatment; 2.2. Secondary objectives. To evaluate:
- the effect of treatment on the parameters of global and regional myocardial deformation in the zone of intact myocardium on Day 7 and Weeks 12, 24, 36 and 48 of the treatment;
- the effect of treatment on the parameters of global and regional myocardial deformation depending on TIMI blood flow grade;
- the effect of treatment on systolic and diastolic function of the left ventricle in patients with impaired left ventricular function at baseline, as well as the ability of this treatment to prevent deterioration of left ventricular function in patients with normal left ventricular function at baseline;
- the effect of treatment on heart failure development and progression as assessed using the corresponding clinical diagnostic criteria;
- the effect of treatment on duration and time course of myocardial ischemia using 24 hour ECG monitoring on Day 7 and Weeks 12, 24, 36 and 48 of treatment;
- the effect of treatment on the appearance of new prognostically significant disorders of cardiac rhythm;
- the effect of treatment on pulse wave velocity and cardio-ankle vascular index (CAVI);
- the effect of treatment on intima-media thickness (IMT);
- the effect of treatment on the results of automated quantitative vascular elasticity measurements, pulse wave and pulse pressure;
- the effect of treatment on endothelial function using the reactive hyperemia test;
- the effect of treatment on the time course of blood chemistry parameters (i.e., total cholesterol, HDL, LDL, triglycerides, creatinine, C-reactive protein (CRP), alanine transaminase (ALT), aspartate transaminase (AST) and creatinkinase (CK);
- the safety of treatment;
- the effect of treatment on patient's well-being and quality of life;
- patient compliance with the therapy. 2.3. Scientific novelty of the study It is planned to study, for the first time, the effect of long-term aggressive statin therapy on the functional status of myocardium in the zone of ischemia, lesion and necrosis in patients with STEMI using the two-dimensional strain procedure.
It is planned, for the first time, to comprehensively study the effect of aggressive statin therapy on the status of vasculature, with measuring multiple parameters characterizing the morphofunctional status of elastic and muscular arteries in patients with documented coronary heart disease (CHD).
2.4. Clinical significance of study results. If the proposed hypotheses are confirmed after the primary endpoints described in Section 3 have been reached, new convincing evidence supporting the use of long-term aggressive treatment with Atorvastatin starting from the early stages of myocardial infarction will be obtained. Obviously, the clinical benefits will include the improved prognosis and decreased risk of repeated vascular events. Favorable effects of this therapy on the morphofunctional status of arterial vasculature will play an important role in the treatment of these patients. Positive results of this study can form the basis for planning and conducting larger studies on pleiotropic effects of Atorvastatin in patients with a history of myocardial infarction.
- Primary endpoints
- Statistically significant differences in spatial and velocity parameters of myocardial deformation in the zone of previous STEMI as compared to controls.
- Statistically significant differences in spatial and velocity parameters of myocardial deformation in the intact zone after STEMI as compared to controls.
- Statistically significant differences in intima-media thickness (IMT) according to echo tracking data as compared to controls.
- Statistically significant differences in carotid-femoral pulse wave velocity and CAVI as compared to controls.
- Planning and conducting the study. It is planned to include 200 patients in this randomized, open-label, single-center, prospective, controlled clinical study; these patients will be recruited at the Department of Therapy of the Penza State University Medical Institute.
4.1. Allocation to study groups:
Patients with STEMI will be included in this study:
Group 1: 100 patients with STEMI to receive atorvastatin at a dose of 80 mg per day for 48 weeks; Group 2: 100 patients with STEMI to receive atorvastatin at a dose of 20 mg per day for 48 weeks.
4.2. Planned number of patients: Prescreening - 300 patients; screening and randomization - 200 patients.
4.3. Study design. Patients will be randomized using sealed envelopes numbered with increasing serial numbers from 1 to 200; each envelope will contain information about patient inclusion into Group 1 or Group 2. Information about treatment schedule and dosing regimen will be provided separately.
4.3.1. Treatment regimen, dose titration strategy and combination treatment principles Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study.
Group A patients will start the treatment between 24 and 96 hours after the onset of STEMI:
- Atorvastatin at a dose of 80 mg per day.
Group K patients will start the treatment between 24 and 96 hours after the onset of STEMI:
- Atorvastatin at a dose of 20 mg per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: AtorvastatinGroup A patients will start atorvastatin at a dose of 80 mg/day between 24 and 96 hours after the onset of STEMI |
| Group K | Active comparator | Drug: AtorvastatinGroup K patients will start atorvastatin at a dose of 20 mg/day between 24 and 96 hours after the onset of STEMI |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent Form
- Patients having physical and mental ability to participate in the study
- Patients of both sexes aged 35 to 65 years
- Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels.
- Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30%.
Key exclusion criteria (22 listed)
- A history of repeat or recurrent myocardial infarction;
- A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA);
- Presence of left ventricular hypertrophy confirmed by echocardiography;
- QRS complex exceeding 1.0;
- Ejection fraction less than 40%;
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 |
|---|---|---|
| AtorvastatinAlso: StatinLipid-lowering therapy | Drug | Group A, Group K |
Primary outcome
Cardiovascular events
Time frame: 2 years
Myocardial infarction, Unstable angina, Cardiac death
5 secondary outcomes
Global myocardial strain in the zone of previous STEMI and in the intact zone after STEMI
Time frame: 2 years
Global myocardial strain rate in the zone of previous STEMI and in the intact zone after STEMI
Time frame: 2 years
Intima-media thickness of carotid artery
Time frame: 2 years
Carotid-femoral pulse wave velocity
Time frame: 2 years
Cardiac-ankle vascular index
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Valentin Oleynikov, prof. principal investigator
Head of Therapy Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Myocardial Infarction, run by Penza State University 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 22 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: finished, as of the sponsor's last update on 24 Mar 2020. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular events (time frame: 2 years). 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 24 Mar 2020.