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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02603328
Other study ID # IRB18-0445
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 17, 2018
Est. completion date June 30, 2025

Study information

Verified date October 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/II randomized, placebo-controlled, double-blinded, single-site clinical trial is designed to investigate the effect of a prolonged course of atorvastatin versus placebo on CCM lesional iron deposition assessed by validated quantitative susceptibility mapping (QSM) MRI studies in patients who suffered a symptomatic bleed within the preceding one year.


Description:

This phase I/II randomized, placebo-controlled, double-blinded, single-site clinical trial is designed to investigate the effect of a prolonged course of atorvastatin versus placebo on CCM lesional iron deposition assessed by validated quantitative susceptibility mapping (QSM) MRI studies in patients who suffered a symptomatic bleed within the preceding one year. Subjects will also be assessed by lesional and brain vascular permeability MRI using dynamic contrast enhanced quantitative perfusion (DCEQP) and a number of clinical evaluation tools. Subjects shall be followed for 2 years from randomization, the period of highest likelihood of rebleed after a recent CCM hemorrhage. Subjects will undergo clinical and MRI evaluations at baseline, and at 12 and 24 months during the study period. Enrolled subjects and the treating team will be blinded to treatment group allocation.


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Study Design


Intervention

Drug:
Atorvastatin
40-80 mg OD
Other:
Placebo
inactive

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean percent change in lesional QSM per year (called the change score) Each patient contributes two outcome measurements (at year 1 and year 2) based on intention-to-treat. Evaluation of the intervention on this outcome will be performed as a time-averaged difference between two arms using a repeated measures analysis implemented as an unadjusted linear mixed model. Patients with outcome measurements in both periods will be included in the initial intention-to-treat analysis. In cases with multiple lesions, only QSM measurements in the lesion with initial hemorrhage (index lesion) shall be considered for the primary outcome assessment. End of study (24-month) MRI scan
Primary Percent QSM change per year A secondary analysis of the percent QSM change per year shall be conducted per treatment rendered for all patients with at least one annual epoch of measurements. End of study (24-month) MRI scan
Secondary Changes in DCEQP vascular permeability measurements in the index lesion and in brain (white matter far from lesion) Changes in DCEQP vascular permeability measurements in the index lesion and in brain (white matter far from lesion) End of study (24-month) MRI scan
Secondary Rates of QSM and DCEQP biomarker events Rates of QSM and DCEQP biomarker events, representing increases in index lesional QSM or DCEQP above previously articulated "biomarker thresholds"; rates of clinically overt hemorrhages in the index lesion per adjudicated criteria; and rates of lesional expansion, defined as an increase in maximum lesion diameter on T2 sequences by 2 or more mm End of study (24-month) MRI scan
Secondary Adverse event rates End of study (24-month) MRI scan
Secondary Serious adverse event rates End of study (24-month) MRI scan
Secondary Drug compliance by tracking daily medication bottle opening We plan to use a compliance device that would record every time the bottle was opened, thus allowing the study team to track compliance with the protocol and help keep subjects accountable. End of study (24-month) MRI scan
Secondary Changes in functional outcome as measured using the modified Rankin scale which measures the degree of disability or dependence in patients with neurological disability. Using the modified Rankin scale, we will track subjects' functional outcome changes over the course of the trial. End of study (24-month) MRI scan
Secondary Impact of sex on primary and secondary outcomes (pre specified subgroup analyses) End of study (24-month) MRI scan
Secondary Impact of genotype on primary and secondary outcomes (pre specified subgroup analyses) End of study (24-month) MRI scan
Secondary Impact of lesion location on primary and secondary outcomes (pre specified subgroup analyses) End of study (24-month) MRI scan
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