drugset / Trial / NCT06603363
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Recruiting
140 enrolled
Prof. Maurovich-Horvat Pál
HeartFlow, Inc. · collabNational Research, Development and Innovation Office, Hungary · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2025-05-28
- Primary completion
- 2026-10-15
- Completion
- 2028-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rosuvastatin | Small molecule | 40 mg | Oral |