Risk Reduction in Coronary Heart Disease (SPREK!)

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

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

Condition Intervention
Coronary Heart Disease
Behavioral: smoking cessation
Drug: betablocker, diuretics, ACEI, ARB,
Drug: statins, ezetimibe
Behavioral: training
Biological: influenza vaccine
Drug: metformin, glimepiride, insulin
Behavioral: weight reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study

Resource links provided by NLM:

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • New cardiovascular events (MACE) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: September 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multifactorial intervention
Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin
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
No Intervention: Controll
no intervention


Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • acute myocardial infarction, CABG or PCI

Exclusion Criteria:

  • Age < 18 and age > 80
  • pregnant
  • critical illness
  • drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679237

Contact: Jarle Jortveit, MD 004737014000 jarle.jortveit@sshf.no

Sorlandet Hospital Recruiting
Arendal, Norway
Contact: Jarle Jortveit, MD    00473714000    jarle.jortveit@sshf.no   
Sponsors and Collaborators
Sorlandet Hospital HF
Oslo University Hospital
Study Chair: Serena Tonstad, dr.med. Ullevaal University Hospital
  More Information

No publications provided

Responsible Party: Sissel Ledang, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00679237     History of Changes
Other Study ID Numbers: S-07041a (REK)
Study First Received: July 5, 2007
Last Updated: April 11, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Natriuretic Agents
Hypoglycemic Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents

ClinicalTrials.gov processed this record on April 23, 2014