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Trial Outcomes & Findings for STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines) (NCT NCT02943590)

NCT ID: NCT02943590

Last Updated: 2025-05-15

Results Overview

To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of\>10% from prior to chemotherapy to a final value of \<55% over 12 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

12 months

Results posted on

2025-05-15

Participant Flow

1:1 randomization

Participant milestones

Participant milestones
Measure
Placebo
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day
Atorvastatin
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day
Overall Study
STARTED
150
150
Overall Study
COMPLETED
144
142
Overall Study
NOT COMPLETED
6
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=150 Participants
Placebo group
Atorvastatin
n=150 Participants
Atorvastatin group
Total
n=300 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
130 Participants
n=5 Participants
130 Participants
n=7 Participants
260 Participants
n=5 Participants
Age, Categorical
>=65 years
20 Participants
n=5 Participants
20 Participants
n=7 Participants
40 Participants
n=5 Participants
Age, Continuous
49 years
STANDARD_DEVIATION 16 • n=5 Participants
50 years
STANDARD_DEVIATION 17 • n=7 Participants
50 years
STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male
Female
74 Participants
n=5 Participants
68 Participants
n=7 Participants
142 Participants
n=5 Participants
Sex: Female, Male
Male
76 Participants
n=5 Participants
82 Participants
n=7 Participants
158 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
White
131 Participants
n=5 Participants
135 Participants
n=7 Participants
266 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
Region of Enrollment
Canada
10 participants
n=5 Participants
10 participants
n=7 Participants
20 participants
n=5 Participants
Region of Enrollment
United States
140 participants
n=5 Participants
140 participants
n=7 Participants
280 participants
n=5 Participants
LVEF
62.5 %
STANDARD_DEVIATION 4.9 • n=5 Participants
63 %
STANDARD_DEVIATION 4.5 • n=7 Participants
63 %
STANDARD_DEVIATION 4.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of\>10% from prior to chemotherapy to a final value of \<55% over 12 months.

Outcome measures

Outcome measures
Measure
Placebo
n=144 Participants
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day
Atorvastatin
n=142 Participants
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day
The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.
22 Participants
9 Participants

SECONDARY outcome

Timeframe: 2 years

To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines.

Outcome measures

Outcome measures
Measure
Placebo
n=144 Participants
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day
Atorvastatin
n=142 Participants
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day
The Percentage of Participants in Each Group With New Onset Heart Failure.
6 Participants
3 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: Persons with available and high quality MRI data where the variable could be measured.

The myocardial extracellular volume (ECV) is the proportion of the myocardium that is estimated to be of extracellular space. Myocardium consists of intracellular space and extracellular space. This measure is an imaging estimate of the extracellular space. The extracellular space can be expanded in diseases where myocardial fibrosis is increased. Thus, this measure is often used as an estimate for the proportion of fibrosis in the heart. It can be expressed as a percentage. Here, based on published literature, we used a cut off of a 3% increase in the ECV from baseline to follow-up as a meaningful increase and compared the propositions of persons with that 3% increase in each group. We are comparing the proportion of persons in each group with a 3% or greater increase in the ECV.

Outcome measures

Outcome measures
Measure
Placebo
n=62 Participants
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day
Atorvastatin
n=65 Participants
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day
Myocardial Extracellular Volume by Cardiac MRI.
29 Participants
8 Participants

SECONDARY outcome

Timeframe: 1 year

Population: The number of persons in each group with high quality imaging data where the variable could be analyzed.

GLS is a sensitive measure of cardiac systolic function. Anthracyclines can be associated with impaired global longitudinal strain (GLS). Whether atorvastatin protects against a decline in LV GLS is unknown. GLS is expressed as a percentage. A ≥15% relative decrease in LV GLS was used as a cut off for a significant decrease in GLS based on published data. The Proportions of participants with a relative reduction of ≥15% in LV GLS were evaluated in each group.

Outcome measures

Outcome measures
Measure
Placebo
n=90 Participants
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day
Atorvastatin
n=98 Participants
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day
Global Longitudinal Strain (GLS)
28 Participants
19 Participants

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 21 other events
Deaths: 4 deaths

Atorvastatin

Serious events: 0 serious events
Other events: 28 other events
Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=150 participants at risk
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day
Atorvastatin
n=150 participants at risk
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day
Musculoskeletal and connective tissue disorders
Muscle pain
14.0%
21/150 • 12 months
No difference
18.7%
28/150 • 12 months
No difference

Additional Information

Tomas Neilan

MassGH

Phone: 617726200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place