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RECRUITING
NCT06603363
NA

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

Sponsor: Prof. Maurovich-Horvat Pál

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-05-28

Completion Date

2028-12-15

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

DRUG

Rosuvastatin 40mg

Participants will receive 40 mg of rosuvastatin once a day for 3 months. After the 3-month visit, the dose will be reduced to a dose per standard of care.

DRUG

Placebo

Participants will receive a placebo for rosuvastatin once a day for 3 months. After the 3-month visit, standard rosuvastatin will be initiated.

DIAGNOSTIC_TEST

Coronary Computed Tomography Angiography (Coronary CTA)

Computed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography at baseline, 3-month, and 24-month visits with a PCD-CT scanner.

DIAGNOSTIC_TEST

Blood test

Blood test at baseline, 3-month, and 24-month visits.

Locations (1)

Semmelweis University, Medical Imaging Centre

Budapest, Budapest, Hungary