Trial · NCT02603328
Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial
NCT02603328, Phase 1, Phase 2, Completed, University of Chicago; results first posted 2025-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial. Trials, record NCT02603328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02603328
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial
- NCT number
- NCT02603328
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Cerebral Cavernous Malformation
- Interventions
- Atorvastatin, Placebo
- First posted
- 2015-11-11
- Last updated
- 2025-08-22
- Results first posted
- 2025-08-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Mean Lesional QSM (QSM Change Score) | 2 years of follow-up | 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 the lesion, which means more blood is present in the lesion. |
| Secondary | Percent Change in Dynamic Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) in Index Lesion (Lesional DCEQP Change Score) | 2 years of follow-up | DCEQP change score is the absolute value of the Percent Change in DCEQP value of the index lesion, presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs DCEQP measures vascular permeability and perfusion, in this case as measured in the index lesion. A higher DCEQP value reflects higher permeability in the lesion. |
| Secondary | Compare the Changes in Modified Rankin Score Between Atorvastatin and Placebo Groups at the Year 1 Follow-up Visit | 1 year of follow-up | Compare the changes in modified Rankin Score between atorvastatin and placebo groups at the year 1 follow-up visit. The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent. |
| Secondary | Compare the Changes in Modified Rankin Score Between Atorvastatin and Placebo Groups at the Year 2 Follow-up Visit. | 1 year of follow-up (from year 1 to year 2) | Compare the changes in modified Rankin Score between atorvastatin and placebo groups at the year 2 follow-up visit (change between mRS score at year 1 follow up visit and year 2 follow up visit). The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent. |
| Secondary | Mean Score of European Quality of Life Visual Analogue Scale (EQ-VAS) at the Year 1 Follow-up Visit. | 1 year of follow up | Mean score of European Quality of Life Visual Analogue Scale (EQ-VAS) at the year 1 follow-up visit The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. |
| Secondary | Mean Score of European Quality of Life Visual Analogue Scale (EQ-VAS) at the Year 2 Follow-up Visit | 1 year of follow up (from year 1 to year 2) | Mean score of European Quality of Life Visual Analogue Scale (EQ-VAS) at the year 2 follow-up visit The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. |
| Secondary | Compare Rate of Drug Compliance in Atorvastatin vs Placebo Group | 2 years of follow-up | Compare number of subjects with 90% or greater protocol compliance throughout the 2 year follow-up period |
| Secondary | Mean Percent Change in Rho-associated Protein Kinase (ROCK) Activity in Peripheral Blood Leukocytes From Baseline to Year 1 | 1 year of follow-up | Compare the mean percent change in peripheral blood leukocyte ROCK activity between atorvastatin and placebo groups from baseline to year 1 |
| Secondary | Mean Percent Change in Rho-associated Protein Kinase (ROCK) Activity in Peripheral Blood Leukocytes From Baseline to Year 2 | 2 year follow-up | Compare the mean percent change in peripheral blood leukocyte ROCK activity between atorvastatin and placebo groups from baseline to year 2 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Mean Lesional QSM (QSM Change Score) | 2 years of follow-up | absolute value of percent change | MEAN | |
| SECONDARY | Percent Change in Dynamic Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) in Index Lesion (Lesional DCEQP Change Score) | 2 years of follow-up | percent change | MEAN | |
| SECONDARY | Compare the Changes in Modified Rankin Score Between Atorvastatin and Placebo Groups at the Year 1 Follow-up Visit | 1 year of follow-up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare the Changes in Modified Rankin Score Between Atorvastatin and Placebo Groups at the Year 2 Follow-up Visit. | 1 year of follow-up (from year 1 to year 2) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Score of European Quality of Life Visual Analogue Scale (EQ-VAS) at the Year 1 Follow-up Visit. | 1 year of follow up | score on a scale | MEAN | |
| SECONDARY | Mean Score of European Quality of Life Visual Analogue Scale (EQ-VAS) at the Year 2 Follow-up Visit | 1 year of follow up (from year 1 to year 2) | score on a scale | MEAN | |
| SECONDARY | Compare Rate of Drug Compliance in Atorvastatin vs Placebo Group | 2 years of follow-up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Percent Change in Rho-associated Protein Kinase (ROCK) Activity in Peripheral Blood Leukocytes From Baseline to Year 1 | 1 year of follow-up | percent change | MEAN | |
| SECONDARY | Mean Percent Change in Rho-associated Protein Kinase (ROCK) Activity in Peripheral Blood Leukocytes From Baseline to Year 2 | 2 year follow-up | percent change | MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Mean Lesional QSM (QSM Change Score) | Treatment | QSM change score by assigned treatment; year 1 minus baseline | 7.35 | Standard Error 9.77 | absolute value of percent change |
| Percent Change in Mean Lesional QSM (QSM Change Score) | Placebo | QSM change score by assigned treatment; year 1 minus baseline | 0.24 | Standard Error 10.08 | absolute value of percent change |
| Percent Change in Mean Lesional QSM (QSM Change Score) | Treatment | QSM change score by assigned treatment; year 2 minus year 1 | 15.18 | Standard Error 10.80 | absolute value of percent change |
| Percent Change in Mean Lesional QSM (QSM Change Score) | Placebo | QSM change score by assigned treatment; year 2 minus year 1 | 26.80 | Standard Error 11.22 | absolute value of percent change |
| Percent Change in Dynamic Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) in Index Lesion (Lesional DCEQP Change Score) | Treatment | Mean lesional DCEQP percent change by assigned treatment; year one minus baseline | 103.40 | Standard Error 40.64 | percent change |
| Percent Change in Dynamic Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) in Index Lesion (Lesional DCEQP Change Score) | Placebo | Mean lesional DCEQP percent change by assigned treatment; year one minus baseline | 35.69 | Standard Error 50.59 | percent change |
| Percent Change in Dynamic Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) in Index Lesion (Lesional DCEQP Change Score) | Treatment | Mean lesional DCEQP percent change by assigned treatment; year two minus year one | 124.52 | Standard Error 85.15 | percent change |
| Percent Change in Dynamic Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) in Index Lesion (Lesional DCEQP Change Score) | Placebo | Mean lesional DCEQP percent change by assigned treatment; year two minus year one | 124.82 | Standard Error 88.92 | percent change |
| Compare the Changes in Modified Rankin Score Between Atorvastatin and Placebo Groups at the Year 1 Follow-up Visit | Treatment | mRS 0 | 2 | Participants | |
| Compare the Changes in Modified Rankin Score Between Atorvastatin and Placebo Groups at the Year 1 Follow-up Visit | Placebo | mRS 0 | 8 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment 80mg | 41 | |
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | Completed Year 1 | Treatment 80mg | 34 | |
| Overall Study | Completed Year 1 | Placebo | 36 | |
| Overall Study | Lowered to 40mg Dose in Year 1 | Treatment 80mg | 1 | |
| Overall Study | Lowered to 40mg Dose in Year 1 | Placebo | 0 | |
| Overall Study | Completed Year 2 | Treatment 80mg | 31 | |
| Overall Study | Completed Year 2 | Placebo | 31 | |
| Overall Study | Lowered to 40mg Dose in Year 2 | Treatment 80mg | 0 | |
| Overall Study | Lowered to 40mg Dose in Year 2 | Placebo | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hepatitis, type unknown | Infections and infestations | Atorvastatin 80mg | 2 | 40 | 2 |
| other | Hepatitis, type unknown | Infections and infestations | Atorvastatin 40mg | 0 | 1 | 0 |
| other | Hepatitis, type unknown | Infections and infestations | Placebo | 0 | 39 | 0 |
| other | Bladder infection | Infections and infestations | Atorvastatin 80mg | 1 | 40 | 1 |
| other | Bladder infection | Infections and infestations | Atorvastatin 40mg | 0 | 1 | 0 |
| other | Bladder infection | Infections and infestations | Placebo | 0 | 39 | 0 |
| other | COVID | Infections and infestations | Atorvastatin 80mg | 5 | 40 | 5 |
| other | COVID | Infections and infestations | Atorvastatin 40mg | 0 | 1 | 0 |
| other | COVID | Infections and infestations | Placebo | 4 | 39 | 4 |
| other | Urinary Tract Infection | Infections and infestations | Atorvastatin 80mg | 1 | 40 | 1 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin 80mg | 0 | 40 |
| Total, all-cause mortality | Atorvastatin 40mg | 0 | 1 |
| Total, all-cause mortality | Placebo | 0 | 39 |
| Total, other adverse events | Atorvastatin 80mg | 27 | 40 |
| Total, other adverse events | Atorvastatin 40mg | 1 | 1 |
| Total, other adverse events | Placebo | 21 | 39 |
| Total, serious adverse events | Atorvastatin 80mg | 1 | 40 |
| Total, serious adverse events | Atorvastatin 40mg | 1 | 1 |
| Total, serious adverse events | Placebo | 0 | 39 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment vs Placebo: Compare Rate of Drug Compliance in Atorvastatin vs Placebo Group |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02603328
GET https://conductscience.org/api/trials/v1/NCT02603328/results?page=2