Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery

NCT ID: NCT07064135

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to find out if patients who receive extra support stay on their cholesterol-lowering therapy and therefore have lower cholesterol levels after 4 months. Extra support means regular phone calls and close monitoring before and after carotid artery surgery. The study compares this approach to usual care.

Participants will:

Be randomly assigned to either standard care or extra support for 4 months. Receive cholesterol-lowering treatment and attend follow-up visits.

Detailed Description

Cardiovascular risk factors are one of the leading causes of morbidity and mortality worldwide. Improving these often fails due to the lack of low-threshold access to specialized medical care. Especially in vascular surgery departments with multimorbid patients, optimizing the management of risk factors-particularly cholesterol-is essential.

This exploratory randomized controlled pilot study aims to investigate the effects of pharmacological optimization of cholesterol management after carotid surgery with subsequent follow-up visits. For this purpose, 50 patients who are undergoing carotid surgery due to carotid stenosis will be randomized into two groups. In Group 1, 25 patients who have not reached the lipid target at the time of surgery will be included and re-evaluated regarding their therapy after 2 months and undergo another ambulatory cholesterol check after 4 months. In Group 2, 25 patients who also have not reached the lipid target at the time of surgery will be included and, after optimization of therapy during the hospital stay, will undergo an ambulatory cholesterol check after 4 months.

Conditions

Dyslipidaemias; Carotid Artery Stenoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intensive Follow-up

Participants in this arm receive prompt adjustment of lipid-lowering medication to achieve target LDL-C levels, combined with intensive follow-up visits and laboratory monitoring 6-8 weeks post-surgery to optimize lipid management.

Group Type: EXPERIMENTAL

Prompt Medication Adjustment and Intensive Follow-up

Intervention Type: BEHAVIORAL

Participants receive prompt adjustment of lipid-lowering therapy perioperatively and 6-8 weeks after carotid endarterectomy to achieve guideline-recommended LDL-C targets, combined with intensive follow-up visits and laboratory monitoring. Intensive follow-up visits and laboratory monitoring of lipid parameters are performed at 6-8 weeks and again at 12-16 weeks postoperatively to optimize lipid management.

Standard Care

Participants in this arm receive standard postoperative care according to current guidelines, including routine follow-up and lipid management without additional early intervention or intensive monitoring.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

Participants receive standard postoperative care according to guidelines, including lipid management and routine follow-up without additional early intervention or intensive monitoring. Lipid parameters are assessed only once at 12-16 weeks postoperatively.

Interventions

Prompt Medication Adjustment and Intensive Follow-up

Participants receive prompt adjustment of lipid-lowering therapy perioperatively and 6-8 weeks after carotid endarterectomy to achieve guideline-recommended LDL-C targets, combined with intensive follow-up visits and laboratory monitoring. Intensive follow-up visits and laboratory monitoring of lipid parameters are performed at 6-8 weeks and again at 12-16 weeks postoperatively to optimize lipid management.

Intervention Type: BEHAVIORAL

Standard Care

Participants receive standard postoperative care according to guidelines, including lipid management and routine follow-up without additional early intervention or intensive monitoring. Lipid parameters are assessed only once at 12-16 weeks postoperatively.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >17 years
• Diagnosed carotid artery stenosis
• Planned carotid endarterectomy
• LDL cholesterol >55 mg/dL
• Willingness to participate, documented by written informed consent

Exclusion Criteria

• Ongoing treatment with PCSK9 inhibitors
• Carotid surgery for reasons other than stenosis (e.g., traumatic injury)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Kepler University of Linz

OTHER

Sponsor Role: collaborator

Barmherzige Brüder Linz

OTHER

Sponsor Role: lead

Responsible Party

Rainer Hintenberger

Senior Physician, Department of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Clodi, Professor, MD

Role: STUDY_DIRECTOR

Konventspital Barmherzige Brüder Linz

Juergen Falkensammer, Associate Professor, MD

Role: STUDY_CHAIR

Konventspital Barmherzige Brüder Linz

Locations

Konventhospital Barmherzige Brüder

Linz, Upper Austria, Austria

Countries

Austria

Central Contacts

Rainer Hintenberger, MD

Role: CONTACT

rainer.hintenberger@bblinz.at

+43 676 4295509

Matthias Heinzl, MD

Role: CONTACT

matthias.heinzl@bblinz.at

+43 676 5206829

Facility Contacts

Martina Gojevic, B.Sc.

Role: primary

martina.gojevic@bblinz.at

+43 732 7897 26311

Rainer Hintenberger, MD

Role: backup

rainer.hintenberger@bblinz.at

+43 732 7897 26350

Other Identifiers

IMACS-2025

Identifier Type: -

Identifier Source: org_study_id