Trial Outcomes & Findings for Statin Therapy in Young Adult Survivors of Childhood Cancer (NCT NCT01733953)

NCT ID: NCT01733953

Last Updated: 2016-12-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Baseline and 6-Months

Results posted on

2016-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Atorvastatin 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Overall Study STARTED	14	13
Overall Study COMPLETED	9	6
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Statin Therapy in Young Adult Survivors of Childhood Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atorvastatin n=14 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=13 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily	Total n=27 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	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	26.9 years STANDARD_DEVIATION 6.9 • n=7 Participants	26.8 years STANDARD_DEVIATION 6.2 • n=5 Participants
Gender Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6-Months

Population: Physician withdrawals, loss to follow-up, drug compliance \<70%, unrelated injury, and self-withdrawal reduced number analyzed. Also, participant movement during FMD assessment and/or poor ultrasound image quality due to difficult brachial artery anatomy or poor circulation led to some unusable data and thus lowered the analyzable sample size.

Outcome measures

Outcome measures
Measure	Atorvastatin n=8 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=3 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months	-0.5 percentage change Interval -2.9 to 1.9	-3.4 percentage change Interval -7.3 to 0.6

SECONDARY outcome

Timeframe: Baseline and 6-Months

Population: Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.

Carotid Artery Compliance is a measure of arterial stiffness. Higher arterial stiffness places persons at higher risk for CVD.

Outcome measures

Outcome measures
Measure	Atorvastatin n=9 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=5 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Change From Baseline in Carotid Artery Compliance at 6-Months	-.34 mm/mmHg x 10^-3 Interval -1.4 to 0.7	0.57 mm/mmHg x 10^-3 Interval -0.8 to 2.0

SECONDARY outcome

Timeframe: Baseline and 6-Months

Population: Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.

Outcome measures

Outcome measures
Measure	Atorvastatin n=9 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=5 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Change From Baseline in Carotid Artery Distensibility at 6-Months	0.31 % distensibility Interval -1.28 to 1.9	0.33 % distensibility Interval -1.81 to 2.47

SECONDARY outcome

Timeframe: Baseline and 6-Months

Population: Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.

Outcome measures

Outcome measures
Measure	Atorvastatin n=9 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=5 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Change From Baseline in Pulse Wave Velocity at 6-Months	-0.52 m/s Interval -2.06 to 1.02	-0.3 m/s Interval -2.36 to 1.76

SECONDARY outcome

Timeframe: Baseline and 6-Months

Population: Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.

Outcome measures

Outcome measures
Measure	Atorvastatin n=9 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=4 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Change From Baseline in Augmentation Index at 6-Months	-0.66 P2/P1 Interval -15.38 to 14.06	-6.01 P2/P1 Interval -24.16 to 12.15

SECONDARY outcome

Timeframe: Baseline and 6-Months

Population: Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.

Outcome measures

Outcome measures
Measure	Atorvastatin n=9 Participants 6-Months Atorvastatin Therapy; 40mg oral, once daily Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.	Sugar Pill (Placebo) n=5 Participants 6-Months Placebo (sugar pill); oral, once daily Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily
Change From Baseline in Carotid Intima-Media Thickness at 6-Months	-.01 mm Interval -0.03 to 0.01	0.01 mm Interval -0.02 to 0.04

Adverse Events

Atorvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cameron Naughton

University of Minnesota

Phone: 612-625-3623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place