Secondary Prevention in Coronary Heart Disease - Full Text View

Secondary Prevention in Coronary Heart Disease (SPREK!)

This study is currently recruiting participants.

Verified by Sorlandet Hospital HF, May 2008

First Received: July 5, 2007 Last Updated: May 14, 2008 History of Changes

Sponsor:	Sorlandet Hospital HF
Collaborator:	Ullevaal University Hospital
Information provided by:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00679237

Purpose

Secondary prevention in coronary heart disease

Condition	Intervention
Coronary Heart Disease	Behavioral: smoking cessation Drug: betablocker, diuretics, ACEI, ARB, moxonidine Drug: statins (simvastatin, atorvastatin), ezetimib Behavioral: training Biological: influenzavaccine Drug: metformin, glimepiride, insulin

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Secondary Prevention in Coronary Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Quitting Smoking

Drug Information available for: Insulin Moxonidine Simvastatin Glimepiride Atorvastatin Atorvastatin calcium Metformin

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:

Risk factor reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	950
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator	Behavioral: smoking cessation NRT and varenicline Drug: betablocker, diuretics, ACEI, ARB, moxonidine blood pressure control according to ESC guidelines Drug: statins (simvastatin, atorvastatin), ezetimib Cholesterol reduction according to ESC guidelines Behavioral: training daily walking Biological: influenzavaccine vaccine (FLuarix, Influvac etc) Drug: metformin, glimepiride, insulin s.glucose control according to ESC guidelines
Controll: No Intervention without intervention

Arms

Assigned Interventions

I: Active Comparator

Behavioral: smoking cessation

NRT and varenicline

Drug: betablocker, diuretics, ACEI, ARB, moxonidine

blood pressure control according to ESC guidelines

Drug: statins (simvastatin, atorvastatin), ezetimib

Cholesterol reduction according to ESC guidelines

Behavioral: training

daily walking

Biological: influenzavaccine

vaccine (FLuarix, Influvac etc)

Drug: metformin, glimepiride, insulin

s.glucose control according to ESC guidelines

Controll: No Intervention

without intervention

Detailed Description:

Risk factor reduction in coronary heart disease

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:	Sorlandet Hospital HF ( Jarle Jortveit )
Study ID Numbers:	S-07041a (REK)
Study First Received:	July 5, 2007
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00679237 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:

Antimetabolites
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Myocardial Ischemia
Diuretics
Physiological Effects of Drugs
Arteriosclerosis
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents

Arterial Occlusive Diseases
Heart Diseases
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Immunosuppressive Agents
Pharmacologic Actions
Coronary Disease
Moxonidine
Natriuretic Agents

ClinicalTrials.gov processed this record on February 08, 2010