Intensive Statin Therapy in Patients With AMI (INTENSIFY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Soren Auscher, Svendborg Hospital
ClinicalTrials.gov Identifier:
NCT01923077
First received: August 9, 2013
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Drug: Simvastatin
Drug: Rosuvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Intensive Treatment With Statins Improves Left Ventricular Function in Patients With Acute Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Svendborg Hospital:

Primary Outcome Measures:
  • Change in Global and Regional longitudinal systolic strain [ Time Frame: baseline, 1 month and 12 month ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • Change in endothelial function and inflammatory activity [ Time Frame: baseline, 1 month and 12 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment of change in Plaque-volume and Plaque-morphology; Stabile Plaque vs. Vulnerable Plaque

  • Cardiovascular events and mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Follow-up after 5 years to register cardiovascular events and mortality


Enrollment: 140
Study Start Date: April 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923077

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

No publications provided

Responsible Party: Soren Auscher, MD, ph.d-student., Svendborg Hospital
ClinicalTrials.gov Identifier: NCT01923077     History of Changes
Other Study ID Numbers: INTENSIFY
Study First Received: August 9, 2013
Last Updated: August 14, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Svendborg Hospital:
acute myocardial infarction
Statin
speckle tracking echocardiography
Strain
MSCT
plaque
vulnerable plaque

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Rosuvastatin
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014