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Risk Reduction in Coronary Heart Disease (SPREK!)

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.
ClinicalTrials.gov Identifier: NCT00679237
Recruitment Status : Active, not recruiting
First Posted : May 16, 2008
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
Actual Study Start Date : September 2007
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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: Control
no intervention


Outcome Measures

Primary Outcome Measures :
  1. New cardiovascular events (MACE) [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679237


Locations
Norway
Sorlandet Hospital
Arendal, Norway
Sponsors and Collaborators
Sorlandet Hospital HF
Oslo University Hospital
Investigators
Study Chair: Serena Tonstad, dr.med. Ullevaal University Hospital
More Information

Responsible Party: Sissel Ledang, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00679237     History of Changes
Other Study ID Numbers: S-07041a (REK)
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vaccines
Glimepiride
Insulin
Metformin
Ezetimibe
Diuretics
Adrenergic beta-Antagonists
Immunologic Factors
Physiological Effects of Drugs
Hypoglycemic Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Natriuretic Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents