Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study - Full Text View

Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study (SPREK!)

This study is currently recruiting participants.

Verified December 2011 by Sorlandet Hospital HF

First Received on July 5, 2007. Last Updated on December 21, 2011 History of Changes

Sponsor:	Sorlandet Hospital HF
Collaborator:	Ullevaal University Hospital
Information provided by (Responsible Party):	Sissel Ledang, Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00679237

Purpose

Multifactorial risk reduction in coronary heart disease reduces the risk of new coronary heart disease and death

Condition	Intervention
Coronary Heart Disease	Behavioral: smoking cessation Drug: betablocker, diuretics, ACEI, ARB, Drug: statins (simvastatin, atorvastatin), ezetimib 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:

MedlinePlus related topics: Coronary Artery Disease Diabetes Medicines Heart Diseases Quitting Smoking Smoking Statins

Drug Information available for: Insulin Simvastatin Glimepiride Atorvastatin Atorvastatin calcium Ezetimibe Fluvirin Influenza Vaccines Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:

new cardiovascular events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1600
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: multifactorial intervention intervention group	Behavioral: smoking cessation NRT and varenicline Drug: betablocker, diuretics, ACEI, ARB, blood pressure control according to ESC guidelines Drug: statins (simvastatin, atorvastatin), ezetimib 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 without intervention

Arms

Assigned Interventions

Active Comparator: multifactorial intervention

intervention group

Behavioral: smoking cessation

NRT and varenicline

Drug: betablocker, diuretics, ACEI, ARB,

blood pressure control according to ESC guidelines

Drug: statins (simvastatin, atorvastatin), ezetimib

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

without 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

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

Ullevaal 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:	December 21, 2011
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Diuretics
Glimepiride
Metformin
Simvastatin
Atorvastatin
Ezetimibe

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
Hypolipidemic Agents
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012