BridgeMD
Tests treatment safety and results for Coronary Artery Disease
Official title Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
ClinicalTrials.gov ID: NCT07254572
What this study is testing
What is Semaglutide 14 MG [Rybelsus]?
Semaglutide 14 MG [Rybelsus] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months. The diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18 - 80
- Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of \>2.5 mm or status after percutaneous...
- Coronary CT scan performed \<3 months after inclusion in the study, at least of good quality
- Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization...
- Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks
You likely can't join if
- Severe valvular defect
- Clinical condition requiring surgical treatment of coronary artery disease
- Status after coronary artery bypass surgery
- Diagnosed diabetes or Hba1c\>=6.5% at screening/randomization appointment
- Other severe medical conditions requiring scheduled hospital treatment at the time of the study
- Severe musculoskeletal conditions requiring specific rehabilitation recommendations
See the full eligibility criteria
- Age 18 - 80
- Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of \>2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan)
- Coronary CT scan performed \<3 months after inclusion in the study, at least of good quality
- Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization appointment or within 30 days prior to the screening/randomization appointment)...
- Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks
- Willing and able to give informed consent to participate in the study
- Willing and able, according to the researcher, to comply with all the requirements of the study
- Severe valvular defect
- Clinical condition requiring surgical treatment of coronary artery disease
- Status after coronary artery bypass surgery
- Diagnosed diabetes or Hba1c\>=6.5% at screening/randomization appointment
- Other severe medical conditions requiring scheduled hospital treatment at the time of the study
- Severe musculoskeletal conditions requiring specific rehabilitation recommendations
- Diagnosed heart failure
- Presence of an artificial valve, cardiac pacing system or other implantable device (such as a cardioverter defibrillator)
- Severe arrhythmia/unexplained loss of consciousness
- Other contraindications to physical activity
- No consent to participate in the study
- Use of glucose-lowering drugs other than metformin
- Use of weight-loss drugs
- Condition after bariatric surgery
- Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment
- Uncompensated hyperthyroidism
- Pancreatic cancer
- Medullary thyroid cancer
- History of anaphylactic shock after iodine contrast administration
- Chronic kidney disease (eGFR \<45 ml/min/1.73 m2)
- History of pancreatitis or active pancreatitis
- Body mass index (BMI) \>40 kg/m2
- Pregnancy/lactation
- Participation in another clinical trial
- Other known contraindications to treatment with metformin, dapagliflozin or semaglutide
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.