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CompletedNCT00679237SPREK!Updated Mar 17, 2021

Risk Reduction in Coronary Heart Disease

An interventional study of smoking cessation and betablocker, diuretics, ACEI, ARB, in Coronary Heart Disease, sponsored by Sorlandet Hospital HF. Completed at 1 site in Norway. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Sorlandet Hospital HF · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,600
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death

02

Conditions studied

  • Coronary Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 1,600 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Sorlandet Hospital HF is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • acute myocardial infarction, CABG or PCI

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 and age > 80
  • pregnant
  • critical illness
  • drug abuse
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,600 participants (actual)

Study arms

  • Active comparator
    Multifactorial intervention

    Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin

    Behavioral: smoking cessation · Drug: betablocker, diuretics, ACEI, ARB, · Drug: statins, ezetimibe · Behavioral: training · Biological: influenza vaccine · Drug: metformin, glimepiride, insulin · Behavioral: weight reduction

  • No intervention
    Control

    no intervention

Interventions

  • Behavioralsmoking cessation

    NRT and varenicline

  • Drugbetablocker, diuretics, ACEI, ARB,

    blood pressure control according to ESC guidelines

  • Drugstatins, ezetimibe

    Cholesterol reduction according to ESC guidelines

  • Behavioraltraining

    daily walking

  • Biologicalinfluenza vaccine

    vaccine (FLuarix, Influvac etc)

  • Drugmetformin, glimepiride, insulin

    s.glucose control according to ESC guidelines

  • Behavioralweight reduction

    diet tips

06

What researchers measure

Primary outcomes

  1. New cardiovascular events (MACE)

    Time frame: 3 years

07

Study locations

1 site
  • Sorlandet Hospital
    Arendal, Norway
08

References and documents

Publications

  • Kaldal A, Tonstad S, Jortveit J. Long-term hospital-based secondary prevention of coronary artery disease: a randomized controlled trial. BMC Cardiovasc Disord. 2021 Dec 16;21(1):600. doi: 10.1186/s12872-021-02426-3. PubMed 34915839 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00679237
Lead sponsor
Sorlandet Hospital HF
Collaborators
Oslo University Hospital
Responsible party
Sissel Ledang (Sorlandet Hospital HF, Sorlandet Hospital HF) — Principal investigator
First posted
May 16, 2008
Start date
Sep 2007
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Mar 17, 2021

Study contacts

Serena Tonstad, dr.med.
study chair · Ullevaal University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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