Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

INTENSE Trial is a prospective, double-blind, randomized, placebo-controlled, single-center study with two arms (40 mg intensified statin therapy vs matching placebo for rosuvastatin) among statin-naive patients referred to coronary CT angiography due to stable chest pain, followed for 24 months by using a photon-counting detector CT (PCD-CT). INTENSE Trial aims 1) to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2) to determine the impact of short-term, intensified statin therapy on coronary plaque morphology and hemodynamics to identify statin responder and non-responder patients in addition to testing the hypothesis of plaque memory after the 24-month follow-up period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• patients referred for coronary computed tomography angiography (CTA)

• females aged 45-75 years and males aged 40-75 years

• presence of at least mild coronary atherosclerosis (luminal stenosis \>25%, with at least one partially calcified or non-calcified plaque)

• statin-naive patients

• ability to understand and provide written informed consent

• FFR-CT value ≥0.75, indicating the absence of hemodynamically significant stenosis

Locations
Other Locations
Hungary
Semmelweis University, Medical Imaging Centre
RECRUITING
Budapest
Contact Information
Primary
Pál Maurovich-Horvat, Prof., Dr.
maurovich-horvat.pal@semmelweis.hu
+36206632485
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2028-12-15
Participants
Target number of participants: 140
Treatments
Experimental: Intensified Statin Arm
Participants will receive one capsule (40 mg of rosuvastatin), taken once daily for 3 months, orally with or without food. After the 3-month visit, the dose will be reduced to a dose per standard of care.
Placebo_comparator: Placebo Arm
Participants will receive one capsule (a placebo for rosuvastatin), taken once daily for 3 months, orally with or without food. After the 3-month visit standard rosuvastatin therapy will be initiated.
Sponsors
Leads: Prof. Maurovich-Horvat Pál
Collaborators: National Research, Development and Innovation Office, Hungary, HeartFlow, Inc.

This content was sourced from clinicaltrials.gov

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