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Niacin Plus Statin to Prevent Vascular Events

This study has been terminated.
(AIM-HIGH was stopped on the recommendation of the DSMB because of lack of efficacy of niacin in preventing primary outcome events.)
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Information provided by (Responsible Party):
Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier:
NCT00120289
First received: July 6, 2005
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: June 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cardiovascular Diseases
Heart Diseases
Cerebrovascular Accident
Coronary Disease
Atherosclerosis
Myocardial Infarction
Interventions: Drug: Extended release niacin
Drug: Simvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
ERN + Simvastatin

Extended release niacin plus simvastatin

Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated

Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target

Placebo + Simvastatin

Simvastatin alone

Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target


Participant Flow:   Overall Study
    ERN + Simvastatin   Placebo + Simvastatin
STARTED   1718   1696 
COMPLETED   1597   1587 
NOT COMPLETED   121   109 
Death                96                82 
Lost to Follow-up                11                14 
Withdrawal by Subject                14                13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat

Reporting Groups
  Description
ERN + Simvastatin

Extended release niacin plus simvastatin

Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated

Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target

Placebo + Simvastatin

Simvastatin alone

Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target

Total Total of all reporting groups

Baseline Measures
   ERN + Simvastatin   Placebo + Simvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 1718   1696   3414 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   917   915   1832 
>=65 years   801   781   1582 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.7  (8.8)   63.7  (8.7)   63.7  (8.7) 
Gender 
[Units: Participants]
     
Female   253   251   504 
Male   1465   1445   2910 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   63   77   140 
Not Hispanic or Latino   1654   1619   3273 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   11   11   22 
Asian   20   21   41 
Native Hawaiian or Other Pacific Islander   7   5   12 
Black or African American   68   49   117 
White   1572   1576   3148 
More than one race   40   33   73 
Unknown or Not Reported   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   1179   1167   2346 
Canada   539   529   1068 
Lipids and Lipoproteins at Baseline 
[Units: mg/dL]
Mean (Standard Deviation)
     
LDL-C   74.2  (23.4)   74.0  (22.7)   74.1  (23) 
HDL-C   34.5  (5.6)   34.9  (5.6)   34.7  (5.6) 
Triglycerides   183.5  (66.7)   181.9  (66.9)   182.7  (66.8) 
non-HDL cholesterol   110.8  (27.5)   110.3  (26)   110.6  (26.8) 
HDL2-C   6  (2.3)   6.2  (2.4)   6.1  (2.3) 
HDL3-C   28.5  (4.2)   28.7  (4.1)   28.6  (4.1) 
Apolipoprotein A-I   122.4  (16.2)   123.7  (16.3)   123.1  (16.2) 
Apolipoprotein B   83.2  (20.2)   82.9  (20.7)   83  (20.4) 
Lipoprotein (a)   77.3  (87.8)   75.5  (89.6)   76.4  (88.7) 
Clinical History 
[Units: Participants]
     
History of myocardial infarction (MI)   968   955   1923 
History of CABG   600   627   1227 
History of Percutaneous Coronary Intervention   1057   1044   2101 
History of stroke or cerebrovascular disease   358   362   720 
History of peripheral vascular disease   234   231   465 
Metabolic syndrome   1414   1353   2767 
History of diabetes (Type 1 or 2)   588   570   1158 
Concomitant Medications at Baseline 
[Units: Participants]
     
Statins   1595   1601   3196 
Beta-blockers   1377   1342   2719 
ACE inhibitor or Angiotensin Receptor Blocker   1258   1271   2529 
Aspirin or other antiplatelet or anticoagulant   1680   1654   3334 


  Outcome Measures
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1.  Primary:   Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization   [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months. ]

2.  Secondary:   Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke   [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months ]

3.  Secondary:   Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke   [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months ]

4.  Secondary:   Cardiovascular Mortality   [ Time Frame: Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Ruth McBride
Organization: Axio Research, LLC
phone: 206-577-0212
e-mail: ruthm@axioresearch.com


Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier: NCT00120289     History of Changes
Other Study ID Numbers: 226
U01HL081649 ( US NIH Grant/Contract Award Number )
U01HL081616 ( US NIH Grant/Contract Award Number )
Study First Received: July 6, 2005
Results First Received: June 1, 2015
Last Updated: March 8, 2016
Health Authority: United States: Federal Government