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

• ClinicalTrials.gov Identifier: NCT02943590
• Recruitment Status: Completed
• First Posted: October 24, 2016
• Results First Posted: December 18, 2023
• Last Update Posted: December 18, 2023
• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; Brigham and Women's Hospital
• Information provided by (Responsible Party): Tomas G. Neilan, MD, Massachusetts General Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Heart Failure
• Interventions: Drug: Placebo; Drug: Atorvastatin
• Enrollment: 300

Participant Flow

Recruitment Details
Pre-assignment Details	1:1 randomization

Arm/Group Title	Placebo	Atorvastatin
Arm/Group Description	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 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
Period Title: Overall Study
Started	150	150
Completed	144	142
Not Completed	6	8

Baseline Characteristics

Arm/Group Title		Placebo	Atorvastatin	Total
Arm/Group Description		Placebo group	Atorvastatin group	Total of all reporting groups
Overall Number of Baseline Participants		150	150	300
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	150 participants	300 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	130 86.7%	130 86.7%	260 86.7%
	>=65 years	20 13.3%	20 13.3%	40 13.3%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	150 participants	150 participants	300 participants
		49 (16)	50 (17)	50 (16)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	150 participants	300 participants
	Female	74 49.3%	68 45.3%	142 47.3%
	Male	76 50.7%	82 54.7%	158 52.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	150 participants	300 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	7 4.7%	4 2.7%	11 3.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 2.7%	5 3.3%	9 3.0%
	White	131 87.3%	135 90.0%	266 88.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	8 5.3%	6 4.0%	14 4.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	150 participants	150 participants	300 participants
Canada		10	10	20
United States		140	140	280
LVEF; Mean (Standard Deviation); Unit of measure: %
	Number Analyzed	150 participants	150 participants	300 participants
		62.5 (4.9)	63 (4.5)	63 (4.6)

Outcome Measures

1. Primary Outcome

Title	The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Atorvastatin
Arm/Group Description:	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 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 Number of Participants Analyzed	144	142
Measure Type: Count of Participants; Unit of Measure: Participants
	22 15.3%	9 6.3%

2. Secondary Outcome

Title	The Percentage of Participants in Each Group With New Onset Heart Failure.
Description	To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Atorvastatin
Arm/Group Description:	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 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 Number of Participants Analyzed	144	142
Measure Type: Count of Participants; Unit of Measure: Participants
	6 4.2%	3 2.1%

3. Secondary Outcome

Title	Myocardial Extracellular Volume by Cardiac MRI.
Description	To determine if anthracyclines lead to an increase in myocardial fibrosis, myocardial extracellular volume, as measured by cardiac MRI and whether statins attenuate the increase in myocardial fibrosis.
Time Frame	1 Year

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Global Longitudinal Strain
Description	To determine whether anthracyclines lead to a reduction in global longitudinal strain (GLS), whether the reduction in GLS associates with the decline in LVEF and whether statins attenuate the anthracycline-associated reduction in GLS.
Time Frame	1 Year

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Troponin
Description	To determine if anthracyclines lead to an increase in serum troponin, to determine if the increase in serum troponin related to the decline in cardiac function and whether statins attenuate the increase in serum troponin.
Time Frame	1 year

Outcome Measure Data Not Reported

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	No difference
Arm/Group Title	Placebo	Atorvastatin
Arm/Group Description	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 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
All-Cause Mortality
	Placebo	Atorvastatin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/150 (2.67%)	4/150 (2.67%)
Serious Adverse Events
	Placebo	Atorvastatin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/150 (0.00%)	0/150 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Atorvastatin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	21/150 (14.00%)	28/150 (18.67%)
Musculoskeletal and connective tissue disorders
Muscle pain †	21/150 (14.00%)	28/150 (18.67%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Tomas Neilan
• Organization: MassGH
• Phone: 617726200
• EMail: tneilan@partners.org

• Responsible Party: Tomas G. Neilan, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02943590
• Other Study ID Numbers: 16-440
• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Results First Submitted: October 18, 2023
• Results First Posted: December 18, 2023
• Last Update Posted: December 18, 2023