Coronary Artery DiseasePhase 4NCT02744976
Coronary Artery Disease Progression in Patients With Prediabetes
A Phase 4 study testing Metformin and Lifestyle recommendations in people with Coronary Artery Disease and Atherosclerosis, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
Trial summary
Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Prediabetic State
- What is being tested?
- Metformin and Lifestyle recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteLatvia
- Study dates
- Feb 2016to Sep 2021
- 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
- age ≥18 and <75 years;
- patients with stable coronary artery disease referred to PCI in an artery suitable for IVUS pullback;
- signed informed consent before PCI.
Who cannot join
- cardiac or non-cardiac illness with life expectancy of less than two years;
- failure to advance the IVUS catheter through the culprit lesion;
- acute coronary syndrome
- congestive heart failure (New York Heart Association (NYHA) classification stage III-IV)
- diabetes mellitus
- chronic kidney disease
Show all 9Show fewer
- previous PCI in the target vessel
- heavily calcified vessels
- allergy to metformin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Artery Disease Progression by iMap Intravascular Ultrasound Analysis in Patients With Prediabetes
Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up.
The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.
Read the detailed description
Patients undergoing PCI and IVUS pullback for the target vessel will be enrolled in a prospective study. Before PCI and at 24 month follow up fasting blood will be collected for glucose, HbA1c, C peptide, lipid profile assessment. Patients' baseline demographic characteristics, medical history, and procedural data will be collected during the index hospitalization and at 24 month follow up. Patients will be divided in groups according to HbA1c - control group (HbA1c<5.7) and prediabetic patients (HbA1c 5.7-6.4). PCI will be performed in accordance with the guidelines. After successful treatment of the culprit lesion IVUS will be done. Following PCI and IVUS patients with prediabetes will be randomly assigned in groups either receiving metformin at a dose of 2000 mg once daily plus standard lifestyle recommendations or standard lifestyle recommendations only. Intravascular ultrasound analysis will be repeated 24 months after the initial PCI.
- Conditions
- Coronary Artery Disease, Atherosclerosis, Prediabetic State
- Being tested
- Metformin, Lifestyle recommendations
- Keywords
- Coronary artery disease, Atherosclerosis, Prediabetes, Intravascular ultrasound, Insulin resistance, Percutaneous coronary intervention, Metformin
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage extended release (XR)
In order to minimize gastrointestinal discomfort, metformin treatment will be started with a dose of 500 mg p/o once daily, then gradually increased to 2000 mg p/o once daily for 24 months
Lifestyle recommendationsBehavioural
Standard lifestyle recommendations
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes, metformin | Experimental | Patients with HbA1c 5.7-6.4 receiving metformin and lifestyle recommendations Receives: Drug: Metformin; Behavioral: Lifestyle recommendations |
| Prediabetes, lifestyle | Active comparator | Patients with HbA1c 5.7-6.4 receiving lifestyle recommendations Receives: Behavioral: Lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage plaque volume change over 24 months
Changes in plaque volume in 24 months
Measured: 24 months
Secondary outcomes (4)
Culprit lesion in-stent restenosis
Neointimal hyperplasia at 24 month follow up
Measured: 24 months
Plaque tissue component percentage change over 24 months
Percentage change in necrotic, fibrotic, lipidic and calcific tissue volume
Measured: 24 months
Correlation of glycemic parameters with plaque characteristics
Correlation of glycemic parameters with plaque characteristics
Measured: At index hospitalization and follow up (24 months)
Plaque volume change in metformin vs non-metformin treated patients over 24 months
Plaque volume change in metformin vs non-metformin treated patients over 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion31 Jul 2019
- Study completionSep 2021
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karlis Trusinskis, Pauls Stradins Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744976
- Sponsor's protocol ID
- IVUS-0216
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2016
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Disease Progression by iMap Intravascular Ultrasound Analysis in Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT02744976
- Acronym / sponsor ID
- IVUS-0216
- Conditions
- Coronary Artery Disease, Atherosclerosis, Prediabetic State
- Keywords
- Coronary artery disease, Atherosclerosis, Prediabetes, Intravascular ultrasound, Insulin resistance, Percutaneous coronary intervention, Metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 20 Apr 2016 (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.
Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up.
The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.
Detailed description
Patients undergoing PCI and IVUS pullback for the target vessel will be enrolled in a prospective study. Before PCI and at 24 month follow up fasting blood will be collected for glucose, HbA1c, C peptide, lipid profile assessment. Patients' baseline demographic characteristics, medical history, and procedural data will be collected during the index hospitalization and at 24 month follow up. Patients will be divided in groups according to HbA1c - control group (HbA1c<5.7) and prediabetic patients (HbA1c 5.7-6.4). PCI will be performed in accordance with the guidelines. After successful treatment of the culprit lesion IVUS will be done. Following PCI and IVUS patients with prediabetes will be randomly assigned in groups either receiving metformin at a dose of 2000 mg once daily plus standard lifestyle recommendations or standard lifestyle recommendations only. Intravascular ultrasound analysis will be repeated 24 months after the initial PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediabetes, metformin | Experimental | Drug: Metformin, Behavioral: Lifestyle recommendationsPatients with HbA1c 5.7-6.4 receiving metformin and lifestyle recommendations |
| Prediabetes, lifestyle | Active comparator | Behavioral: Lifestyle recommendationsPatients with HbA1c 5.7-6.4 receiving lifestyle recommendations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 and <75 years;
- patients with stable coronary artery disease referred to PCI in an artery suitable for IVUS pullback;
- signed informed consent before PCI.
Key exclusion criteria (9 listed)
- cardiac or non-cardiac illness with life expectancy of less than two years;
- failure to advance the IVUS catheter through the culprit lesion;
- acute coronary syndrome
- congestive heart failure (New York Heart Association (NYHA) classification stage III-IV)
- diabetes mellitus
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 |
|---|---|---|
| MetforminAlso: Glucophage extended release (XR)In order to minimize gastrointestinal discomfort, metformin treatment will be started with a dose of 500 mg p/o once daily, then gradually increased to 2000 mg p/o once daily for 24 months | Drug | Prediabetes, metformin |
| Lifestyle recommendationsStandard lifestyle recommendations | Behavioural | Prediabetes, lifestyle, Prediabetes, metformin |
Primary outcome
Percentage plaque volume change over 24 months
Time frame: 24 months
Changes in plaque volume in 24 months
4 secondary outcomes
Culprit lesion in-stent restenosis
Time frame: 24 months
Plaque tissue component percentage change over 24 months
Time frame: 24 months
Correlation of glycemic parameters with plaque characteristics
Time frame: At index hospitalization and follow up (24 months)
Plaque volume change in metformin vs non-metformin treated patients over 24 months
Time frame: 24 months
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 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metformin and Lifestyle recommendations in people with Coronary Artery Disease and Atherosclerosis, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
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 9 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 Apr 2022. 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 Latvia. 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?
Percentage plaque volume change over 24 months (time frame: 24 months). 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 Apr 2022.