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Risk Reduction in Coronary Heart Disease (SPREK!)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679237
First Posted: May 16, 2008
Last Update Posted: August 10, 2017
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.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Sissel Ledang, Sorlandet Hospital HF
  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
Intervention Model: Parallel Assignment
Masking: None (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 Sissel Ledang, Sorlandet Hospital HF:

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

Enrollment: 1600
Actual Study Start Date: September 2007
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (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: Control
no intervention

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: July 5, 2007
First Posted: May 16, 2008
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