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Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation

NCT05251129 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-01-13

No results posted yet for this study

Summary

The investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (HS) can reduce CAV in comparison to lower intensity statin (LS) after HT. All consecutive patients that meet eligibility criteria will be approached for participation. After heart transplantation, participants (n=70) will be randomized in a 1:1 manner to either HS or LS. Study participation will be for 2 years from the time of randomization. Study outcomes will be compared by research staff blinded to statin group assignment.

Conditions

  • Vasculopathy

Interventions

DRUG

Atorvastatin 80 Mg Oral Tablet

Higher intensity statin

DRUG

Pravastatin 40 Mg Oral Tablet

Lower intensity statin

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Omar Saeed, MD, MS · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2030-06-30
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251129 on ClinicalTrials.gov