Trial Outcomes & Findings for Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment (NCT NCT00819403)

NCT ID: NCT00819403

Last Updated: 2020-01-14

Results Overview

Measured using whole blood flow cytometry

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2020-01-14

Participant Flow

All patients have been recruited and 15 have successfully completed the study.

Patients excluded included those unable to tolerate statin and/or ezetimibe treatment

Participant milestones

Measure	Simvastatin Then Simvastatin/Ezetimibe Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied.	Simvastatin/Ezetimibe Then Simvastatin Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
First Intervention (6 Weeks) STARTED	7	8
First Intervention (6 Weeks) COMPLETED	7	8
First Intervention (6 Weeks) NOT COMPLETED	0	0
Washout (14 Days) STARTED	7	8
Washout (14 Days) COMPLETED	7	8
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (6 Weeks) STARTED	7	8
Second Intervention (6 Weeks) COMPLETED	7	8
Second Intervention (6 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

Baseline characteristics by cohort

Measure	Simvastatin n=7 Participants Simvastatin 40 mg daily simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.	Simvastatin/Ezetimibe n=8 Participants Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.	Total n=15 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	7 Participants n=5 Participants	8 Participants n=7 Participants	15 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	46.3 years STANDARD_DEVIATION 6.6 • n=5 Participants	50.5 years STANDARD_DEVIATION 12.6 • n=7 Participants	48.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Based on power calculations

Measured using whole blood flow cytometry

Outcome measures

Measure	Simvastatin n=15 Participants Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.	Simvastatin/Ezetimibe n=15 Participants Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression PAR 1/4 antigen	35.4 ng/dl Standard Deviation 5.2	34.5 ng/dl Standard Deviation 5.4
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression PAR 1/4 activity	23.6 ng/dl Standard Deviation 4.3	22.5 ng/dl Standard Deviation 6.2

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Simvastatin n=15 Participants Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.	Simvastatin/Ezetimibe n=15 Participants Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
Biomarkers of Inflammation CRP	3.51 mg/dl Standard Deviation .48	3.57 mg/dl Standard Deviation .34
Biomarkers of Inflammation IL-6	1.24 mg/dl Standard Deviation .12	1.33 mg/dl Standard Deviation .21

Adverse Events

Simvastatin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Simvastatin/Ezetimibe

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Simvastatin n=15 participants at risk Simvastatin 40 mg daily simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.	Simvastatin/Ezetimibe n=15 participants at risk Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
Gastrointestinal disorders GI symptoms	13.3% 2/15 • Number of events 3	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Muscle symptoms	26.7% 4/15 • Number of events 4	0.00% 0/15
Psychiatric disorders Fatigue	13.3% 2/15 • Number of events 2	0.00% 0/15

Additional Information

Dr Michael Miller

Univ Maryland

Phone: 410 328-6299

Email: mmiller@medicine.umaryland.edu

Results disclosure agreements

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