Trial record 3 of 4 for:    aim-high

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:
Abbott
Information provided by (Responsible Party):
Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier:
NCT00120289
First received: July 6, 2005
Last updated: June 1, 2015
Last verified: June 2015
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
No text entered.

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  
Number of Participants  
[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 ]

2.  Secondary:   Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke   [ Time Frame: Time to first event ]

3.  Secondary:   Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke   [ Time Frame: Time to first event ]

4.  Secondary:   Cardiovascular Mortality   [ Time Frame: Time to event ]


  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:

Responsible Party: Ruth McBride, Axio Research. LLC
ClinicalTrials.gov Identifier: NCT00120289     History of Changes
Other Study ID Numbers: 226, U01HL081649, U01HL081616, U01 HL81616, U01 HL81649
Study First Received: July 6, 2005
Results First Received: June 1, 2015
Last Updated: June 1, 2015
Health Authority: United States: Federal Government