Risk Reduction in Coronary Heart Disease (SPREK!)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sorlandet Hospital HF
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Sissel Ledang, Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00679237
First received: July 5, 2007
Last updated: April 11, 2014
Last verified: April 2014

July 5, 2007
April 11, 2014
September 2007
December 2016   (final data collection date for primary outcome measure)
New cardiovascular events (MACE) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Risk factor reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00679237 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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: Controll
    no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2019
December 2016   (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
Both
18 Years to 79 Years
No
Contact: Jarle Jortveit, MD 004737014000 jarle.jortveit@sshf.no
Norway
 
NCT00679237
S-07041a (REK)
No
Sissel Ledang, Sorlandet Hospital HF
Sorlandet Hospital HF
Oslo University Hospital
Study Chair: Serena Tonstad, dr.med. Ullevaal University Hospital
Sorlandet Hospital HF
April 2014

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