Trial Outcomes & Findings for High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly (NCT NCT00127218)

Results Overview

The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

145 participants

Primary outcome timeframe

18 months

Results posted on

2017-11-06

Participant Flow

Participants were randomized in a 1:1 ratio to receive niacin or placebo, using a random number schema stratiﬁed to ensure equal numbers between age 65-74 years and 75 years and above. Study took place in a university outpatient center.

Participants were over age 65 years with a history of cardiovascular events or evidence of atherosclerosis at angiography (\>50% stenosis) or non-invasive imaging, with baseline LDL\<3.24 mmol/L if already on statin therapy and \<3.89 mmol/L if untreated. There were no restrictions on HDL level.

Participant milestones

Participant milestones
Measure	Niacin Plus Statin Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Placebo Plus Statin placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
Overall Study STARTED	72	73
Overall Study COMPLETED	59	58
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Niacin Plus Statin n=72 Participants Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Placebo Plus Statin n=73 Participants placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Total n=145 Participants Total of all reporting groups
Age, Continuous	73 years n=5 Participants	72 years n=7 Participants	73 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	60 Participants n=7 Participants	118 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	73 participants n=7 Participants	145 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.

Outcome measures

Outcome measures
Measure	Niacin Plus Statin n=72 Participants Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Placebo Plus Statin n=73 Participants placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries	7 percentage of internal carotid artery Standard Error .2	5 percentage of internal carotid artery Standard Error .2

SECONDARY outcome

Timeframe: 18 months

Population: Cardiovascular event (stroke) was seen in only 1 patient and 5 patients needed myocardial revascularization

Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded

Outcome measures

Outcome measures
Measure	Niacin Plus Statin n=72 Participants Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Placebo Plus Statin n=73 Participants placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)	6 Participants	2 Participants

Adverse Events

Niacin Plus Statin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Plus Statin

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Niacin Plus Statin n=72 participants at risk Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Placebo Plus Statin n=73 participants at risk placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
Vascular disorders Stroke	1.4% 1/72 • Number of events 1	0.00% 0/73
Vascular disorders Death	0.00% 0/72	1.4% 1/73 • Number of events 1

Other adverse events

Other adverse events
Measure	Niacin Plus Statin n=72 participants at risk Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target	Placebo Plus Statin n=73 participants at risk placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
Vascular disorders Coronary Revascularization	6.9% 5/72 • Number of events 5	2.7% 2/73 • Number of events 2

Additional Information

Dr. Joao AC Lima

The Johns Hopkins Hospital, Department of Medicine, Division of Cardiology

Phone: 410-614-1284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place