Intensive Statin Therapy in Patients With AMI (INTENSIFY)
|ClinicalTrials.gov Identifier: NCT01923077|
Recruitment Status : Unknown
Verified August 2013 by Soren Auscher, Svendborg Hospital.
Recruitment status was: Active, not recruiting
First Posted : August 14, 2013
Last Update Posted : August 15, 2013
Objective: Statins have been shown to have beneficial pleiotropic effects besides being lipid lowering. The investigators hypothesized that early and intensive statin treatment was associated with improved left ventricular (LV) function and with a stabilization of the coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Method: In a prospective randomized blinded endpoint trial patients with ST segment elevation or non ST segment elevation AMI were randomized to either intensive statin-therapy (loading dose rosuvastatin 80 mg immediately after randomization followed by 40 mg daily) or usual statin therapy (simvastatin 40 mg daily). Patients were followed 12 month and the investigators performed echocardiography at randomization, after 30 days and after 12 month. The investigators used 2D Speckle Tracking for the assessment of LV-function. Coronary plaque assessment was done with Cardiac-CT (MSCT) at baseline and after 12 month.
Primary outcome for this study was assessment of LV function with global and regional myocardial strain. Secondary outcomes can be divided in 4 groups:
- Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume, atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.
- Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM, E-selection and Nitrate/Nitrite ratio.
- Coronary plaque assessment by MSCT: Plaque volume and plaque stability.
- Long term follow-up: Mortality and cardiovascular events
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Simvastatin Drug: Rosuvastatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Intensive Treatment With Statins Improves Left Ventricular Function in Patients With Acute Myocardial Infarction.|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
Placebo Comparator: Conventional
Conventional treatment with simvastatin
usual care with Simvastatin
Other Name: Simva
Active Comparator: Rosuvastatin
loading dose of rosuvastatin 80 mg at randomization followed by 40 mg daily in 12 month.
rosuvastatin 80 mg as loading dose at randomization followed by rosuvastatin 40 mg daily.
Other Name: crestor
- Change in Global and Regional longitudinal systolic strain [ Time Frame: baseline, 1 month and 12 month ]We want to investigate if early intensive statin treatment with rosuvastatin improve Global and Regional longitudinal systolic strain assessed by speckle tracking echocardiography compared to patients getting usual care with simvastatin 40 mg
- Change in LV-function assessed by 2D echocardiography: Ejection Fraction, S´, LV-volume, atrial-volume, VA-coupling, diastolic function. Post systolic strain(PSS) and strain rate [ Time Frame: baseline, 1 month, 12 month ]
- Change in endothelial function and inflammatory activity [ Time Frame: baseline, 1 month and 12 month ]Endothelial function estimated by nitrate/nitrite ratio. Inflammatory response estimated by: hs-CRP, ICAM, VCAM, E-selectin,
- Change in Coronary Plaque morphology [ Time Frame: baseline and after 12 month ]Assessment of change in Plaque-volume and Plaque-morphology; Stabile Plaque vs. Vulnerable Plaque
- Cardiovascular events and mortality [ Time Frame: 5 years ]Follow-up after 5 years to register cardiovascular events and mortality
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923077
|Svendborg, Funen, Denmark, 5700|
|Principal Investigator:||Søren SA Auscher, MD||OUH/Svendborg Hospital, Denmark|