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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
  Purpose

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

  Eligibility

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

Inclusion Criteria:

  • acute myocardial infarction, CABG or PCI

Exclusion Criteria:

  • Age < 18 and age > 80
  • pregnant
  • critical illness
  • drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679237

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

Locations
Norway
Sorlandet Hospital Recruiting
Arendal, Norway
Contact: Jarle Jortveit, MD    00473714000    jarle.jortveit@sshf.no   
Sponsors and Collaborators
Sorlandet Hospital HF
Oslo University Hospital
Investigators
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
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases
Diuretics
Ezetimibe
Glimepiride
Metformin
Anti-Arrhythmia Agents
Anticholesteremic Agents
Antimetabolites
Cardiovascular Agents
Hypoglycemic Agents
Hypolipidemic Agents
Immunologic Factors
Immunosuppressive Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014