Comprehensive Magnetic Resonance of Peripheral Arterial Disease

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00587678
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	Drug: Simvastatin; Drug: Ezetimibe; Drug: Simvastatin/Ezetimibe	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comprehensive Magnetic Resonance of Peripheral Arterial Disease
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Randomized Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years	Drug: Simvastatin; 40mg each night; Other Names: Zocor ; Drug: Simvastatin/Ezetimibe; 40mg/10mg each night; Other Names: Vytorin
Experimental: Ezetemibe Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.	Drug: Ezetimibe; 10mg daily; Other Names: Zetia

Outcome Measures

Primary Outcome Measures

1. Plaque Volume [2 years]

   SFA plaque volume

2. Perfusion Index [2 years]

   Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.

3. Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau. [2 years]

   Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.

Secondary Outcome Measures

1. Low Density Lipoprotein Cholesterol [2 years]

2. Total Cholesterol [2 years]

3. High Density Lipoprotein Cholesterol [2 years]

4. Triglycerides [2 years]

5. Magnetic Resonance Angiographic Index [2 years]

   MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.

6. Log Treadmill Exercise Time [2 years]

7. 6-minute Walk Distance [2 years]

8. V02 - Maximal Oxygen Consumption [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4<ABI<0.9) 96 Normal healthy subjects ages 30-85

Exclusion Criteria:

Age<30, >85

GFR less than 45mL/min based on a serum creatinine drawn within 90 days of the MRI:

Pregnancy Contraindications to a magnetic resonance examination

• Intracranial clips

• Implantable pacemaker and defibrillator

• Cochlear or intraocular implants

• Claustrophobia

• Any metallic implant not listed as magnetic resonance compatible in Shellock F.G ---Pocket Guide to Magnetic Resonance Procedures and Metallic Objects, Update 2000. Lippincott, Williams and Wilkins

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virgina Health System	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia
• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Christopher M Kramer, M.D., University of Virginia Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

• Isbell DC, Berr SS, Toledano AY, Epstein FH, Meyer CH, Rogers WJ, Harthun NL, Hagspiel KD, Weltman A, Kramer CM. Delayed calf muscle phosphocreatine recovery after exercise identifies peripheral arterial disease. J Am Coll Cardiol. 2006 Jun 6;47(11):2289-95. Epub 2006 May 15.
• Isbell DC, Epstein FH, Zhong X, DiMaria JM, Berr SS, Meyer CH, Rogers WJ, Harthun NL, Hagspiel KD, Weltman A, Kramer CM. Calf muscle perfusion at peak exercise in peripheral arterial disease: measurement by first-pass contrast-enhanced magnetic resonance imaging. J Magn Reson Imaging. 2007 May;25(5):1013-20.
• Isbell DC, Meyer CH, Rogers WJ, Epstein FH, DiMaria JM, Harthun NL, Wang H, Kramer CM. Reproducibility and reliability of atherosclerotic plaque volume measurements in peripheral arterial disease with cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2007;9(1):71-6. Erratum in: J Cardiovasc Magn Reson. 2007;9(3):629.
• Kramer CM. Peripheral arterial disease assessment: wall, perfusion, and spectroscopy. Top Magn Reson Imaging. 2007 Oct;18(5):357-69.

• Responsible Party: Christopher M. Kramer MD, Professor of Radiology and Medicine, University of Virginia
• ClinicalTrials.gov Identifier: NCT00587678
• Other Study ID Numbers: 10387; R01HL075792
• First Posted: Jan 7, 2008
• Last Update Posted: Aug 21, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by Christopher M. Kramer MD, Professor of Radiology and Medicine, University of Virginia: PAD
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Simvastatin; Ezetimibe

Study Results

Participant Flow

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Period Title: Overall Study
STARTED	22	22	41
COMPLETED	16	18	33
NOT COMPLETED	6	4	8

Baseline Characteristics

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg	Total
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years	Total of all reporting groups
Overall Participants	22	22	41	85
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	16 72.7%	11 50%	20 48.8%	47 55.3%
>=65 years	6 27.3%	11 50%	21 51.2%	38 44.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (12)	64 (9)	66 (11)	63 (11)
Sex: Female, Male (Count of Participants)
Female	6 27.3%	10 45.5%	21 51.2%	37 43.5%
Male	16 72.7%	12 54.5%	20 48.8%	48 56.5%
Region of Enrollment (participants) [Number]
United States	22 100%	22 100%	41 100%	85 100%
Total cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	194 (11)	189 (10)	170 (6)	182 (45)
Low density lipoprotein cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	118 (10)	118 (9)	100 (4)	111 (35)
High density lipoprotein cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	45 (4)	48 (4)	42 (2)	43 (13)
Triglycerides (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	227 (47)	130 (21)	157 (20)	159 (104)
Plaque volume (cm^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^3]	11.0 (1.5)	11.5 (1.4)	10.0 (0.8)	10.6 (5.4)
Total vessel volume (cm^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^3]	17.7 (2.5)	17.5 (2.4)	15.7 (1.2)	16.6 (8.7)
Lumen volume (cm3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm3]	6.7 (1.2)	5.9 (1.1)	5.7 (0.5)	6.0 (3.8)
Perfusion index (Units on a scale (0 = worst, 1 = best).) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale (0 = worst, 1 = best).]	0.48 (0.18)	0.42 (0.13)	0.51 (0.16)	0.48 (0.16)
Phosphocreatine recovery time constant (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	94 (77)	104 (56)	83 (62)	92 (64)
Magnetic resonance angiographic index (units on a scale (0-4). 0 = normal.) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale (0-4). 0 = normal.]	0.73 (0.50)	1.10 (0.72)	0.65 (0.62)	0.81 (0.64)
Log of Treadmill Exercise Time (log of time in seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [log of time in seconds]	6.08 (0.84)	5.82 (0.67)	5.94 (0.78)	5.95 (0.76)
6-minute walk distance (feet) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [feet]	1103 (407)	976 (324)	1007 (435)	1024 (397)
V02 max - maximal oxygen consumption (ml/kg/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/kg/min]	14.6 (4.6)	12.4 (3.2)	12.1 (3.8)	12.8 (4.0)

Outcome Measures

1. Primary Outcome

Title	Plaque Volume
Description	SFA plaque volume
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [cm^3]	10.5 (1.4)	10.5 (1.3)	10.8 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Linear repeated measures model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	vs. baseline
	Method	Linear repeated measures model
	Comments

2. Secondary Outcome

Title	Low Density Lipoprotein Cholesterol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [mg/dl]	83 (11)	68 (10)	77 (5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Linear repeated measures model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	vs. baseline
	Method	Linear repeated measures model
	Comments

3. Primary Outcome

Title	Perfusion Index
Description	Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [Units on a scale (0 = worst, 1 = best)]	0.34 (0.19)	0.37 (0.13)	0.54 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Linear repeated measures model
	Comments

4. Primary Outcome

Title	Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.
Description	Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [seconds]	84 (68)	73 (35)	74 (58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Linear repeated measures model
	Comments

5. Secondary Outcome

Title	Total Cholesterol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [mg/dl]	152 (12)	136 (12)	144 (6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	Linear repeated measures model
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	vs. baseline
	Method	Linear repeated measures model
	Comments

6. Secondary Outcome

Title	High Density Lipoprotein Cholesterol
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [mg/dl]	44 (4)	46 (3)	43 (3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	Linear repeated measures model
	Comments

7. Secondary Outcome

Title	Triglycerides
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [mg/dl]	171 (30)	119 (20)	152 (15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments
	Method	Linear repeated measures model
	Comments

8. Secondary Outcome

Title	Magnetic Resonance Angiographic Index
Description	MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [units on scale (0 = normal, 4 = worst)]	0.71 (0.46)	1.32 (0.86)	0.63 (0.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Linear repeated measures model
	Comments

9. Secondary Outcome

Title	Log Treadmill Exercise Time
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [log time in seconds]	5.92 (1.08)	5.79 (0.67)	5.78 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.67
	Comments
	Method	linear repeated measures model
	Comments

10. Secondary Outcome

Title	6-minute Walk Distance
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [ft.]	1078 (485)	1038 (248)	1099 (394)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Linear repeated measures model
	Comments

11. Secondary Outcome

Title	V02 - Maximal Oxygen Consumption
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simvastatin 40mg	Simvastatin 40mg/Ezetimibe 10 mg	Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Measure Participants	16	18	33
Mean (Standard Deviation) [ml/min/kg]	14.8 (4.6)	12.1 (2.9)	12.3 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simvastatin 40mg, Simvastatin 40mg/Ezetimibe 10 mg, Ezetimibe 10mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Linear repeated measures model
	Comments

Adverse Events

Arm/Group Title	Simvastatin 40mg		Simvastatin 40mg/Ezetimibe 10 mg		Ezetimibe 10mg
Arm/Group Description	Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years		Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years		Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
All Cause Mortality
	Simvastatin 40mg		Simvastatin 40mg/Ezetimibe 10 mg		Ezetimibe 10mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Simvastatin 40mg		Simvastatin 40mg/Ezetimibe 10 mg		Ezetimibe 10mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/22 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Simvastatin 40mg		Simvastatin 40mg/Ezetimibe 10 mg		Ezetimibe 10mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/41 (0%)

Limitations/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.