NCT01382472

Brief Summary

In this mechanistic pilot study in 40 patients the investigators will compare the findings in patients treated with very early high dose statin therapy with historic controls from the KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose statin therapy in patients treated with primary PCI:

  1. 1.reduces area of myocardial infarction, reduces volumes and improves remodelling as assessed by MRI at 2 days and at 2 months
  2. 2.improves microcirculation (Decreased number of patients with MO) as assessed by first pass time estimated with MRI 2 days
  3. 3.have impact on coronary blood flow as assessed by intravascular registrations and TIMI frame count immediately after PCI
  4. 4.reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and neurohormones at discharge and at 2 months follow-up
  5. 5.improves endothelial function assessed by flow mediated vasodilatation at discharge
  6. 6.alters Peak VO2 at 1 and 6 month
  7. 7.reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at follow-up alters collagen turnover

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 22, 2020

Status Verified

August 1, 2016

Enrollment Period

5.3 years

First QC Date

June 20, 2011

Last Update Submit

October 20, 2020

Conditions

ST Elevation (STEMI) Myocardial Infarction

Keywords

STEMIPPCIStatinsInfarct size

Outcome Measures

Primary Outcomes (1)

  • infarct size

    2 years

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

40 mg rosuvastatin pre PCI and daily during hospital stay

Drug: Rosuvastatin

Historical data (KOMPIS)

OTHER

Patients from the KOMPIS trial (n=44) will be used as historical controls. They received no statins omn the first day. Low dose simvastatin during hospital stay.

Drug: Simvastatin

Interventions

RosuvastatinDRUG

40 mg per operative in PPCI, the 40 daily during hospital stay

Also known as: Crestor-AstraZeneca
Rosuvastatin
SimvastatinDRUG

No statin acutely. Simvastatin 20 mg from day 2.

Historical data (KOMPIS)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Evidence of acute ST elevation myocardial infarct.
  • Planned primary PCI procedure.
  • Obtained written informed consent.
  • "One vessel disease"

You may not qualify if:

  • History of previous myocardial infarction
  • History of valvular disease
  • Ongoing therapy for hyperlipidemia
  • History of heart failure
  • Any active non-cardiac co-morbidity or condition that is likely to compromise patient cooperation or survival during the follow-up period of the study.
  • Pregnancy (In doubt a urine test will be employed before treatment)
  • Lactating females
  • Asians
  • Previous muscle disease
  • Reduced glomerular filtration
  • Active hepatic disease
  • Ongoing oral anticoagulation therapy
  • Ongoing cyclosporine therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stavanger University Hospital

Stavanger, 4068, Norway

Location

University Hospital of North Norway

Tromsø, NO-9038, Norway

Location

St. Olavs Hospital

Trondheim, NO-7006, Norway

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

Rosuvastatin CalciumSimvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Study Officials

  • Alf Inge Larsen, MD, PhD

    Helse Stavanger HF

    STUDY CHAIR

  • Noreen Butt, MD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 27, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 22, 2020

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)