Cardiovascular Atlas
About
Menu

IMPROVE-IT (ezetimibe added to simvastatin after acute coronary syndrome)

A large trial of 18,144 people who had recently been in hospital with an acute coronary syndrome. Everyone took the statin simvastatin, and half also took the cholesterol pill ezetimibe. Adding ezetimibe lowered LDL cholesterol further and gave a small extra reduction in heart and blood-vessel events over 7 years.

Also called IMPROVE-IT · IMProved Reduction of Outcomes: Vytorin Efficacy International Trial

  • Study
  • In this atlas

Overview

Design
Allocation: randomized. Intervention model: parallel. Masking: triple. Primary purpose: treatment. (Registry values, in lower case.)
Phase
Phase 3
Enrolled
  • 18,144 participants (enrolled count) (IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103), retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT00202878
Started
(actual) (IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103), retrieved )
Primary completion
(actual) (IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103), retrieved )
Completion
(actual) (IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103), retrieved )
Results first posted
(IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103), retrieved )
Countries
Not reported
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Phase 3, double-blind randomized trial (NCT00202878): simvastatin 40 mg with ezetimibe 10 mg against simvastatin 40 mg with placebo, 18,144 participants enrolled, 2005-10-17 to 2014-09-18. The abstract reports a 7-year Kaplan-Meier primary event rate of 32.7% against 34.7% (hazard ratio 0.936, 95% CI 0.89 to 0.99). The paper says the trial was funded by Merck; the registry now lists Organon and Co as lead sponsor. The registry names hypercholesterolemia and myocardial infarction as conditions.

Arms

  • ezetimibe/simvastatin

    Intervention None named

    One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.

  • simvastatin

    Intervention None named

    One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.

Findings

No findings are published for this study.

Record details

Record id
cardio:improve-it
Content hash
c1d13da6f261929daaecbcddf23e8bc8ff343f9c9c90de1ed55ce6d57f441804