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Risk Reduction in Coronary Heart Disease (SPREK!)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679237
First Posted: May 16, 2008
Last Update Posted: August 10, 2017
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.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Sissel Ledang, Sorlandet Hospital HF
July 5, 2007
May 16, 2008
August 10, 2017
September 2007
December 2024   (Final data collection date for primary outcome measure)
New cardiovascular events (MACE) [ Time Frame: 3 years ]
Risk factor reduction [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00679237 on ClinicalTrials.gov Archive Site
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Risk Reduction in Coronary Heart Disease
Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Coronary Heart Disease
  • Behavioral: smoking cessation
    NRT and varenicline
  • Drug: betablocker, diuretics, ACEI, ARB,
    blood pressure control according to ESC guidelines
  • Drug: statins, ezetimibe
    Cholesterol reduction according to ESC guidelines
  • Behavioral: training
    daily walking
  • Biological: influenza vaccine
    vaccine (FLuarix, Influvac etc)
  • Drug: metformin, glimepiride, insulin
    s.glucose control according to ESC guidelines
  • Behavioral: weight reduction
    diet tips
  • Active Comparator: Multifactorial intervention
    Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1600
December 2024
December 2024   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute myocardial infarction, CABG or PCI

Exclusion Criteria:

  • Age < 18 and age > 80
  • pregnant
  • critical illness
  • drug abuse
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00679237
S-07041a (REK)
No
Not Provided
Not Provided
Sissel Ledang, Sorlandet Hospital HF
Sorlandet Hospital HF
Oslo University Hospital
Study Chair: Serena Tonstad, dr.med. Ullevaal University Hospital
Sorlandet Hospital HF
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP