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NCT02603328 · ClinicalTrials.gov registry record · Phase 1
Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial
A Phase 1 study of Cerebral Cavernous Malformation, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02603328: Completed Phase 1 study of Cerebral Cavernous Malformation, sponsored by University of Chicago.
NCT02603328 is a Phase 1 study of Cerebral Cavernous Malformation that has completed, run by University of Chicago. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02603328, a Phase 1 study of Cerebral Cavernous Malformation, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
QSM change score is the Percentage Change in mean lesional iron deposition per year (QSM score) according to assigned treatment (modified intention-to-treat cohort), presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs. Quantitative susceptibility mapping (QSM) is a noninvasive MRI technique that assesses iron content by quantifying the magnetic susceptibility of local tissues. A higher QSM value corresponds to a larger amount of iron in
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Atorvastatin
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 1 |
What the finished NCT02603328 record still lists
NCT02603328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Cerebral Cavernous Malformation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02603328 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02603328 about?
NCT02603328 is a clinical study titled "Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial". 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 patient...
What is the current status of trial NCT02603328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2018-07-17. Estimated completion is 2025-03-31.
What conditions does trial NCT02603328 study?
This clinical trial studies the following conditions: Cerebral Cavernous Malformation.
What interventions are being tested in trial NCT02603328?
The interventions under investigation include: Placebo (OTHER), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT02603328?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02603328 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02603328's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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