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

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.

Conditions

• Coronary Artery Disease
• Atherosclerotic Plaque
• Coronary Computed Tomography Angiography
• Statin Therapy
• Multidetector Computed Tomography
• Heart Diseases
• Cardiovascular Diseases
• Arteriosclerosis
• Vascular Diseases
• Hyperlipidemia

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.

Sponsors & Collaborators

• National Research, Development and Innovation Office, Hungary

  collaborator UNKNOWN

• HeartFlow, Inc.

  collaborator INDUSTRY

• Prof. Maurovich-Horvat Pál

  lead OTHER

Principal Investigators

• Pál Maurovich-Horvat, Prof., Dr. · Medical Imaging Centre, Budapest, Hungary

• Marc Dewey, Prof., Dr. · Charite University, Berlin, Germany

• Béla Merkely, Prof., Dr. · Heart and Vascular Centre, Budapest, Hungary

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-28

Primary Completion

2026-10-15

Completion

2028-12-15

Countries

• Hungary

Study Locations