BridgeMD
Semmelweis Lipid Center for High-risk Patients
EU CTIS ID: 2024-519058-35-00
What this study is testing
To show that a decrease in LDL-level is achievable with establishing a complex, intensive lipid management program.
- Therapeutic use (Phase IV)
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
- Male or female ≥ 18 years of age at signing of informed consent
- Subject agrees to the Maximum dose Statin therapy (Rosuvastatin min. 20 mg or Atorvastatin min. 40 mg) Fasting LDL-C local lab value at the Screening Visit ≥ 1.8 mmol/L proved atherosclerotic coronary disease (at least 1 of the below): 1)
- proved atherosclerotic coronary disease (at least 1 of the below): 1) non-obstructive coronary plaques on CT scan in the last 6 months without revascularization, at least in 4 four regions (1-69% stenosis is 2 regions and 25-69% stenosis in 2 other regions); 2)proved acute coronary syndrome in one year with multi-vessel disease (at least 50% stenosis on another artery; post-PCI patient with at least 2 coronary XML File Identifier: ZRG11sdk8OXqmN4mxy3KFqZT0uQ=Page 11/22 arteries involved
- Written informed consent must be obtained before any assessment is performed.
You likely can't join if
- Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- Ongoing malignancy at the time of the first study visit
- Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter must have AST and ALT ≤3x ULN
- Use of other investigational drugs within 5 half-lives of the first study visit (Screening Visit), within 30 days (e.g., small molecules), or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or if required by local regulations. COVID-19 vaccines granted Emergency Use Authorization are not considered investigational drugs for the purpose of this study.
- Heart failure (New York Heart Association (NYHA) class IV) at the Screening Visit.
See the full eligibility criteria
- Male or female ≥ 18 years of age at signing of informed consent
- Subject agrees to the Maximum dose Statin therapy (Rosuvastatin min. 20 mg or Atorvastatin min. 40 mg) Fasting LDL-C local lab value at the Screening Visit ≥ 1.8 mmol/L proved atherosclerotic coronary disease (at least 1 of the below): 1)
- proved atherosclerotic coronary disease (at least 1 of the below): 1) non-obstructive coronary plaques on CT scan in the last 6 months without revascularization, at least in 4 four regions (1-69% stenosis is 2 regions and 25-69% stenosis in 2 other regions); 2)proved acute coronary syndrome in one year with multi-vessel disease (at least 50% stenosis on another artery; post-PCI patient with at least 2 coronary XML File Identifier: ZRG11sdk8OXqmN4mxy3KFqZT0uQ=Page 11/22 arteries involved
- Written informed consent must be obtained before any assessment is performed.
- Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- Ongoing malignancy at the time of the first study visit
- Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter must have AST and ALT ≤3x ULN
- Use of other investigational drugs within 5 half-lives of the first study visit (Screening Visit), within 30 days (e.g., small molecules), or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or if required by local regulations. COVID-19 vaccines granted Emergency Use Authorization are not considered investigational drugs for the purpose of this study.
- Heart failure (New York Heart Association (NYHA) class IV) at the Screening Visit.
- current PCSK-9 inhibitor treatment
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.