Coronary Artery DiseasePhase 4SAFARYNCT04497792
Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
A Phase 4 study testing Empagliflozin 10Mg Tab and hypoglycemic therapy in people with Coronary Artery Disease and Diabetes Mellitus, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia.
Trial summary
Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Percutaneous Coronary Intervention
- What is being tested?
- Empagliflozin 10Mg Tab and hypoglycemic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed inform concent
- stable coronary artery disease
- planned percutaneous coronary intervention
- diabetes mellitus
Who cannot join
- previously performed coronary revascularization
- glomerular filtration rate less than 45 ml/min
- intolerance to empagliflozin
- serum potassium more than 5/5 mmol/l
- heart failure (NYHA III-IV)
- congenital heart disease
- acute coronary syndrome less than 3 months before enrollment
About this study
Official title: A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.
Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes
Read the detailed description
Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.
Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy
- Being tested
- Empagliflozin 10Mg Tab, hypoglycemic therapy
- Keywords
- stable coronary artery disease, empagliflozin
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10Mg TabDrug
Also called metformin
Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
hypoglycemic therapyDrug
Also called metformin
hypoglycemic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment. Receives: Drug: Empagliflozin 10Mg Tab |
| Control group | Other | patients continue previously prescribed medication intake Receives: Drug: hypoglycemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
glomerular filtration rate(GFR)
The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
Measured: baseline-24 weeks
HbA1C level
The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
Measured: baseline-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study startNov 2016
- Primary completionNov 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Barbarash, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Investigators
- Olga Barbarash, Principal investigator, Research Institute for complex issues of cardiovascular diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497792
- Sponsor's protocol ID
- 16_001
- Acronym
- SAFARY
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT04497792
- Acronym / sponsor ID
- SAFARY / 16_001
- Keywords
- stable coronary artery disease, empagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 4 Aug 2020 (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.
Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes
Detailed description
Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.
Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Empagliflozin 10Mg TabThe treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment. |
| Control group | Other | Drug: hypoglycemic therapypatients continue previously prescribed medication intake |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- signed inform concent
- stable coronary artery disease
- planned percutaneous coronary intervention
- diabetes mellitus
Key exclusion criteria (7 listed)
- previously performed coronary revascularization
- glomerular filtration rate less than 45 ml/min
- intolerance to empagliflozin
- serum potassium more than 5/5 mmol/l
- 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 |
|---|---|---|
| Empagliflozin 10Mg TabAlso: metforminPatients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication | Drug | Treatment group |
| hypoglycemic therapyAlso: metforminhypoglycemic therapy. | Drug | Control group |
Primary outcome
glomerular filtration rate(GFR)
Time frame: baseline-24 weeks
The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.
HbA1C level
Time frame: baseline-24 weeks
The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.
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 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Olga Barbarash principal investigator
Research Institute for complex issues of cardiovascular diseases
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10Mg Tab and hypoglycemic therapy in people with Coronary Artery Disease and Diabetes Mellitus, run by Research Institute for Complex Problems of Cardiovascular Diseases, 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 4 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: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
glomerular filtration rate(GFR) (time frame: baseline-24 weeks). The study lists 2 primary outcomes in all. 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 22 Sep 2021.