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REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification (REVEAL)

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ClinicalTrials.gov Identifier: NCT01252953
Recruitment Status : Active, not recruiting
First Posted : December 3, 2010
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Oxford

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Atherosclerotic Cardiovascular Disease
Interventions: Drug: Anacetrapib
Drug: Placebo anacetrapib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized between August 2011 and October 2013. Follow-up continued until 31st January 2017.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Successfully screened participants were entered into a run-in period. Attendees were discouraged from continuing to randomization if it was thought unlikely they would be able to continue attending follow-up visits for at least 4-5years. During run-in participants were issued atorvastatin (1 tablet/day) and placebo anacetrapib (1 tablet/day).

Reporting Groups
  Description
Anacetrapib Anacetrapib: 100mg tablet daily
Placebo Anacetrapib Placebo anacetrapib: 1 tablet daily

Participant Flow:   Overall Study
    Anacetrapib   Placebo Anacetrapib
STARTED   15225   15224 
COMPLETED   15187   15186 
NOT COMPLETED   38   38 
Withdrawal by Subject                16                17 
Lost to Follow-up                22                21 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Anacetrapib Anacetrapib: 100mg tablet daily
Placebo Anacetrapib Placebo anacetrapib: 1 tablet daily
Total Total of all reporting groups

Baseline Measures
   Anacetrapib   Placebo Anacetrapib   Total 
Overall Participants Analyzed 
[Units: Participants]
 15225   15224   30449 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6634  43.6%      6643  43.6%      13277  43.6% 
>=65 years      8591  56.4%      8581  56.4%      17172  56.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (8)   67  (8)   67  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2456  16.1%      2459  16.2%      4915  16.1% 
Male      12769  83.9%      12765  83.8%      25534  83.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      121   0.8%      114   0.7%      235   0.8% 
Not Hispanic or Latino      2560  16.8%      2522  16.6%      5082  16.7% 
Unknown or Not Reported      12544  82.4%      12588  82.7%      25132  82.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
Black or African American      160   1.1%      168   1.1%      328   1.1% 
Chinese      4323  28.4%      4323  28.4%      8646  28.4% 
Other North East Asian      5   0.0%      6   0.0%      11   0.0% 
South Asian      95   0.6%      97   0.6%      192   0.6% 
South East Asian      11   0.1%      11   0.1%      22   0.1% 
White      10561  69.4%      10558  69.4%      21119  69.4% 
Other      47   0.3%      49   0.3%      96   0.3% 
Mixed      21   0.1%      12   0.1%      33   0.1% 
Unknown      2   0.0%      0   0.0%      2   0.0% 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   4204   4177   8381 
Norway   426   418   844 
Sweden   427   434   861 
Denmark   918   932   1850 
Finland   307   306   613 
Germany   755   774   1529 
Italy   826   834   1660 
United States   2687   2643   5330 
Canada   361   391   752 
China   4314   4315   8629 
Previous disease [1] 
[Units: Participants]
Count of Participants
     
Coronary heart disease   13325   13354   26679 
Cerebrovascular disease   3385   3396   6781 
Peripheral-artery disease   1229   1206   2435 
Diabetes   5654   5666   11320 
Heart failure   902   869   1771 
[1] The participants could have more than one of these conditions.
Region 
[Units: Participants]
Count of Participants
     
Europe      7863  51.6%      7875  51.7%      15738  51.7% 
North America      3048  20.0%      3034  19.9%      6082  20.0% 
China      4314  28.3%      4315  28.3%      8629  28.3% 
Systolic Blood Pressure, Categorical 
[Units: Participants]
Count of Participants
     
<125 mmHg      5678  37.3%      5760  37.8%      11438  37.6% 
≥125 to <140 mmHg      4819  31.7%      4740  31.1%      9559  31.4% 
≥140 mmHg      4728  31.1%      4724  31.0%      9452  31.0% 
Systolic Blood Pressure, Continuous 
[Units: mmHg]
Mean (Standard Deviation)
 131.3  (18.5)   131.1  (18.5)   131.2  (18.5) 
Diastolic Blood Pressure, Categorical 
[Units: Participants]
Count of Participants
     
< 75 mmHg      5656  37.1%      5790  38.0%      11446  37.6% 
≥ 75 to < 85 mmHg      5408  35.5%      5277  34.7%      10685  35.1% 
≥ 85 mmHg      4161  27.3%      4157  27.3%      8318  27.3% 
Diastolic Blood Pressure, Continuous 
[Units: mmHg]
Mean (Standard Deviation)
 78.1  (10.9)   78.0  (11.0)   78.1  (11.0) 
Body Mass Index, Categorical [1] 
[Units: Participants]
Count of Participants
     
<25 kg/m^2      3447  22.6%      3361  22.1%      6808  22.4% 
≥25 to < 30 kg/m^2      6949  45.6%      6995  45.9%      13944  45.8% 
≥ 30 kg/m^2      4829  31.7%      4868  32.0%      9697  31.8% 
[1] The body mass index is the weight in kilograms divided by the square of the height in meters.
Body Mass Index, Continuous 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.6  (5.0)   28.6  (5.1)   28.6  (5.1) 
LDL Cholesterol, Categorical 
[Units: Participants]
Count of Participants
     
< 54 mg/dl      5023  33.0%      5077  33.3%      10100  33.2% 
≥ 54 to < 66 mg/dl      4643  30.5%      4705  30.9%      9348  30.7% 
≥ 66 mg/dl      5559  36.5%      5442  35.7%      11001  36.1% 
LDL Cholesterol, Continuous 
[Units: Mg/dl]
Mean (Standard Deviation)
 61  (15)   61  (15)   61  (15) 
Non-HDL Cholesterol, Categorical 
[Units: Participants]
Count of Participants
     
< 85 mg/dl      5642  37.1%      5701  37.4%      11343  37.3% 
≥ 85 to <101 mg/dl      4896  32.2%      4853  31.9%      9749  32.0% 
≥ 101 mg/dl      4687  30.8%      4670  30.7%      9357  30.7% 
Non-HDL Cholesterol, Continuous 
[Units: Mg/dl]
Mean (Standard Deviation)
 92  (19)   92  (19)   92  (19) 
HDL Cholesterol, Categorical 
[Units: Participants]
Count of Participants
     
< 35 mg/dl      4583  30.1%      4590  30.1%      9173  30.1% 
≥ 35 to < 43 mg/dl      5438  35.7%      5269  34.6%      10707  35.2% 
≥ 43 mg/dl      5204  34.2%      5365  35.2%      10569  34.7% 
HDL Cholesterol, Continuous 
[Units: Mg/dl]
Mean (Standard Deviation)
 40  (10)   40  (10)   40  (10) 
Glomerular Filtration Rate, Categorical [1] 
[Units: Participants]
Count of Participants
     
< 60 ml/min/1.73m^2      1655  10.9%      1698  11.2%      3353  11.0% 
≥ 60 ml/min/1.73m^2      13570  89.1%      13526  88.8%      27096  89.0% 
[1]

The estimated glomerular filtration rate was calculated with the use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation as per Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate.

Ann Intern Med 2009; 150(9): 604-12.

Glomerular Filtration Rate, Continuous 
[Units: Ml/min/1.73m^2]
Mean (Standard Deviation)
 83  (17)   83  (17)   83  (17) 


  Outcome Measures

1.  Primary:   Number of Participants With Major Coronary Event   [ Time Frame: Randomized treatment phase during median follow-up period of 4.1years ]

2.  Secondary:   Number of Participants With Major Atherosclerotic Event   [ Time Frame: Randomized treatment phase during median follow-up period of 4.1years ]

3.  Secondary:   Number of Participants With Presumed Ischaemic Stroke   [ Time Frame: Randomized treatment phase during median follow-up period of 4.1years ]

4.  Secondary:   Number of Participants With Major Vascular Event   [ Time Frame: Randomized treatment phase during median follow-up period of 4.1years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof Martin Landray
Organization: Nuffield Department of Population Health, University of Oxford
phone: +44 (0)1865 743743
e-mail: martin.landray@ndph.ox.ac.uk


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

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01252953     History of Changes
Other Study ID Numbers: CTSUREVEAL1
48678192 ( Registry Identifier: ISRCTN )
2010-023467-18 ( EudraCT Number )
First Submitted: November 24, 2010
First Posted: December 3, 2010
Results First Submitted: February 1, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018