CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 145 enrolled
Drug / intervention
any statin +2 moredrug
Likely dose
Fluvastatin 80 mg daily or equivalent statin dose plus long-acting niacin daily for 18 monthsAI-extracted
Key inclusion· 5
  • Age 65 years or older
  • Documented clinical cardiovascular or cerebrovascular disease due to atherosclerosis
  • Candidate for lipid-lowering therapy with no contraindication to fluvastatin, niacin, or aspirin
  • LDL cholesterol <150 mg/dL if untreated or <125 mg/dL on statin monotherapy
Key exclusion· 9
  • Ineligible for MRI due to pacemaker, metal implants, or ferromagnetic devices
  • Claustrophobia
  • Prior esophageal disease precluding trans-esophageal MRI
  • LDL-C >150 mg/dL untreated or requiring statin doses exceeding specified maximums (atorvastatin >20 mg, simvastatin >20 mg, fluvastatin >80 mg, pravastatin >80 mg, rosuvastatin >20 mg)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127218
NCT00127218Phase 3Completed

HDL Increased Plaque Stabilization in the Elderly

Johns Hopkins University·interventional·Posted Aug 5, 2005·Updated Nov 6, 2017

In Brief

A Phase 3 clinical trial evaluating any statin, niacin, and 1 other intervention for Atherosclerosis and Cardiovascular Disease. Completed, enrolled 145 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the added benefits of increased high-density lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines, in older individuals with cardiovascular disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 5, 2005
Enrollment StartSep 1, 2003
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.9 years ago

Interventions

any statindrug

Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months

niacindrug

long-acting niacin daily for 18 months

Placebodrug

matching placebo pill daily for 18 months