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IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00202878
First received: September 13, 2005
Last updated: November 2, 2015
Last verified: November 2015
Results First Received: August 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hypercholesterolemia
Myocardial Infarction
Interventions: Drug: ezetimibe/simvastatin
Drug: simvastatin
Drug: Placebo for simvastatin 40 mg
Drug: Placebo for ezetimibe 10 mg/simvastatin 40 mg combination

  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
Adult men and women presenting with non-ST segment elevation myocardial infarction (NSTEMI) , STEMI, or hospitalized, documented unstable angina (UA) whom a percutaneous coronary intervention (PCI) was planned as management for the qualifying acute coronary syndrome (ACS) event were eligible for entry into the trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study continued until a minimum of 5,250 participants had a primary endpoint event and each participant was followed for a minimum of 2.5 years.

Reporting Groups
  Description
Ezetimibe/Simvastatin One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
Simvastatin One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.

Participant Flow:   Overall Study
    Ezetimibe/Simvastatin   Simvastatin
STARTED   9067   9077 
COMPLETED   6868   6860 
NOT COMPLETED   2199   2217 
Death                964                968 
Only Vital Status Known                357                356 
Lost to Follow-up                44                49 
Site Closure                39                36 
Withdrawal by Subject                795                808 



  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.
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Reporting Groups
  Description
Ezetimibe/Simvastatin One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
Simvastatin One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
Total Total of all reporting groups

Baseline Measures
   Ezetimibe/Simvastatin   Simvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 9067   9077   18144 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.6  (9.7)   63.6  (9.8)   63.6  (9.8) 
Gender 
[Units: Participants]
     
Female   2225   2191   4416 
Male   6842   6886   13728 


  Outcome Measures
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1.  Primary:   Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)   [ Time Frame: Up to approximately 9 years ]

2.  Secondary:   Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)   [ Time Frame: Up to approximately 9 years ]

3.  Secondary:   Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)   [ Time Frame: Up to approximately 9 years ]

4.  Secondary:   Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)   [ Time Frame: Up to approximately 9 years ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


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


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00202878     History of Changes
Other Study ID Numbers: P04103
MK-0653A-080 ( Other Identifier: Merck Study Number )
Study First Received: September 13, 2005
Results First Received: August 28, 2015
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration