BridgeMD
IDEAL-COR
EU CTIS ID: 2023-505270-15-00
What this study is testing
To investigate the effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression, plaque burden, and microvascular function in overweight and obese individuals with stable coronary artery disease.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- BMI equal to or above 25 kg/m2
- Age 18 years or older
- Referred to coronary angiography (CAG) for evaluation of stable coronary disease
- Coronary atheromatosis by angiography (obstructive or non-obstructive)
- max lipid core burden index 4 mm (maxLCBI4mm) >200 by near-infrared spectroscopy (NIRS) in at least one major vessel not subjected to coronary intervention
You likely can't join if
- History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at screening
- Estimated glomerular filtration rate (eGFR <30 ml/min/1.53 m2)
- History of pancreatitis or plasma amylase >3 times upper normal limit
- Pregnancy or planned pregnancy
- Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal)
- Heart transplant recipient
See the full eligibility criteria
- BMI equal to or above 25 kg/m2
- Age 18 years or older
- Referred to coronary angiography (CAG) for evaluation of stable coronary disease
- Coronary atheromatosis by angiography (obstructive or non-obstructive)
- max lipid core burden index 4 mm (maxLCBI4mm) >200 by near-infrared spectroscopy (NIRS) in at least one major vessel not subjected to coronary intervention
- History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at screening
- Estimated glomerular filtration rate (eGFR <30 ml/min/1.53 m2)
- History of pancreatitis or plasma amylase >3 times upper normal limit
- Pregnancy or planned pregnancy
- Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal)
- Heart transplant recipient
- Patient is currently enrolled in another research study that may interfere with the conduct of this study.
- Patient has any medical illness (e.g. cancer) that may cause non-compliance with the protocol or is associated with a life expectancy less than 1 year.
- Inability to understand the requirements of the study and to provide informed consent
- Medical illness requiring long-term treatment with systemic glucocorticoidsteroids
- Patients who will not be available for study-required visits in the judgment of the Investigator
- Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)
- Coronary disease requiring coronary bypass surgery
- Coronary disease requiring complex or high-risk PCI (e.g. chronic total occlusion of a major vessel or need for extensive rotablation).
- Coronary anatomy or pathology precluding the safe performance of intravascular imaging in at least one major vessel not subjected to intervention
- Left main stenosis (≥50% diameter or haemodynamically significant)
- Chronic total occlusion of any major coronary vessel
- Treatment with glucagon-like peptide 1 (GLP-1) agonists
- History of coronary artery bypass surgery (CABG)
- Planned cardiovascular intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of screening or at randomisation
- History of heart failure New York Heart Association (NYHA) class III or IV
- Left ventricular ejection fraction (LVEF) ≤35%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.