Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery

NCT07064135 | Not Yet Recruiting

• 1 other identifier: IMACS-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidaemias; Carotid Artery Stenoses

Keywords

LDL-C lowering; Carotid Endarterectomy; Statins; Lipid Management; Secondary Prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving the LDL-C target of <55 mg/dL

  12-16 weeks

Study Arms (2)

Intensive Follow-up

EXPERIMENTAL

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.

Behavioral: Prompt Medication Adjustment and Intensive Follow-up

Standard Care

ACTIVE COMPARATOR

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.

Other: Standard Care

Interventions

Prompt Medication Adjustment and Intensive Follow-up 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.

Intensive Follow-up

Standard Care 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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Barmherzige Brüder Linz: lead
• Johannes Kepler University of Linz: collaborator

Study Sites (1)

Konventhospital Barmherzige Brüder

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Martin Clodi, Professor, MD

  Konventspital Barmherzige Brüder Linz

  STUDY DIRECTOR

• Juergen Falkensammer, Associate Professor, MD

  Konventspital Barmherzige Brüder Linz

  STUDY CHAIR

Central Study Contacts

Rainer Hintenberger, MD

CONTACT

+43 676 4295509; rainer.hintenberger@bblinz.at

Matthias Heinzl, MD

CONTACT

+43 676 5206829; matthias.heinzl@bblinz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician, Department of Vascular Surgery

Model Details: Two-arm, parallel-group RCT

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

AU (1)