Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction.
NCT01385631 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2014-09-03
Summary
The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe when used in addition to optimal treatment with Atorvastatin in patients with acute ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.
An area with arteriosclerosis not demanding intervention in a coronary vessel other than the infarct related is used as measuring point and is examined at time of the infarction and after 12 month using intravascular ultrasound and optical coherence tomography. At the same time the same techniques are used to examine the implanted stent.
Conditions
- ST-Segment Elevation Myocardial Infarction
Interventions
- DRUG
-
Ezetimibe
100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
- DRUG
-
100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
Sponsors & Collaborators
-
Odense University Hospital
lead OTHER
Principal Investigators
-
Mikkel Hougaard, MD · Department of Cardiology, Odense University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 81 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2014-06-30
- Completion
- 2014-09-30
Countries
- Denmark
Study Locations
More Related Trials
-
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
NCT00653796 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
NCT01370603 ·Status: COMPLETED ·Phase: PHASE3
-
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
NCT03882892 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
NCT00535405 ·Status: COMPLETED ·Phase: PHASE3
-
Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
NCT00654095 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol
NCT01008345 ·Status: COMPLETED ·Phase: PHASE4
-
Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
NCT00319449 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
NCT00871351 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
NCT01370590 ·Status: COMPLETED ·Phase: PHASE3
-
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)
NCT00650689 ·Status: COMPLETED ·Phase: PHASE3
-
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
NCT00418834 ·Status: COMPLETED ·Phase: PHASE3
-
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
NCT00276484 ·Status: COMPLETED ·Phase: PHASE3
-
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
NCT00276458 ·Status: COMPLETED ·Phase: PHASE3
-
Ezetimibe in Patients Hypo-responsive to Statins
NCT00965055 ·Status: TERMINATED ·Phase: PHASE3
-
Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)
NCT00651404 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
NCT00639158 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)
NCT00551447 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
NCT05761444 ·Status: COMPLETED ·Phase: PHASE4
-
Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)
NCT00423488 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
NCT02460159 ·Status: COMPLETED ·Phase: PHASE3
-
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
NCT00782184 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)
NCT00652327 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia
NCT02304926 ·Status: COMPLETED ·Phase: NA
-
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)
NCT00423579 ·Status: COMPLETED ·Phase: PHASE4
-
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
NCT00653523 ·Status: COMPLETED ·Phase: PHASE3