NCT01923077

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. 1.Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume, atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate.
  2. 2.Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM, E-selection and Nitrate/Nitrite ratio.
  3. 3.Coronary plaque assessment by MSCT: Plaque volume and plaque stability.
  4. 4.Long term follow-up: Mortality and cardiovascular events

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

August 9, 2013

Last Update Submit

August 14, 2013

Conditions

Acute Myocardial Infarction

Keywords

acute myocardial infarctionStatinspeckle tracking echocardiographyStrainMSCTplaquevulnerable plaque

Outcome Measures

Primary Outcomes (1)

  • Change in Global and Regional longitudinal systolic strain

    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

    baseline, 1 month and 12 month

Secondary Outcomes (4)

  • 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

    baseline, 1 month, 12 month

  • Change in endothelial function and inflammatory activity

    baseline, 1 month and 12 month

  • Change in Coronary Plaque morphology

    baseline and after 12 month

  • Cardiovascular events and mortality

    5 years

Study Arms (2)

Conventional

PLACEBO COMPARATOR

Conventional treatment with simvastatin

Drug: Simvastatin

Rosuvastatin

ACTIVE COMPARATOR

loading dose of rosuvastatin 80 mg at randomization followed by 40 mg daily in 12 month.

Drug: Rosuvastatin

Interventions

SimvastatinDRUG

usual care with Simvastatin

Also known as: Simva
Conventional
RosuvastatinDRUG

rosuvastatin 80 mg as loading dose at randomization followed by rosuvastatin 40 mg daily.

Also known as: crestor
Rosuvastatin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with NSTEMI and STEMI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUH/Svendborg Hospital

Svendborg, Funen, 5700, Denmark

Location

MeSH Terms

Conditions

Sprains and StrainsPlaque, Amyloid

Interventions

SimvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Søren SA Auscher, MD

    OUH/Svendborg Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ph.d-student.

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 14, 2013

Study Start

April 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

DK(1)