Intensive Statin Therapy in Patients With AMI (INTENSIFY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
University of Southern Denmark
Information provided by (Responsible Party):
Soren Auscher, Svendborg Hospital

Brief Summary:

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:

  1. Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume, atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.
  2. Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM, E-selection and Nitrate/Nitrite ratio.
  3. Coronary plaque assessment by MSCT: Plaque volume and plaque stability.
  4. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Conventional
Conventional treatment with simvastatin
Drug: 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.
Drug: Rosuvastatin
rosuvastatin 80 mg as loading dose at randomization followed by rosuvastatin 40 mg daily.
Other Name: crestor

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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 ]
  2. 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,

  3. 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

  4. Cardiovascular events and mortality [ Time Frame: 5 years ]
    Follow-up after 5 years to register cardiovascular events and mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients with NSTEMI and STEMI

Exclusion Criteria:

  • prior intensive statin treatment
  • contraindication to intensive statin therapy
  • Time limit above 24 hours from hospital admission.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01923077

OUH/Svendborg Hospital
Svendborg, Funen, Denmark, 5700
Sponsors and Collaborators
Svendborg Hospital
University of Southern Denmark
Principal Investigator: Søren SA Auscher, MD OUH/Svendborg Hospital, Denmark

Responsible Party: Soren Auscher, MD, ph.d-student., Svendborg Hospital Identifier: NCT01923077     History of Changes
Other Study ID Numbers: INTENSIFY
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013

Keywords provided by Soren Auscher, Svendborg Hospital:
acute myocardial infarction
speckle tracking echocardiography
vulnerable plaque

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors