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Risk Reduction in Coronary Heart Disease (SPREK!)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
smoking cessation
betablocker, diuretics, ACEI, ARB,
statins, ezetimibe
training
influenza vaccine
metformin, glimepiride, insulin
weight reduction
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute myocardial infarction, CABG or PCI

Exclusion Criteria:

  • Age < 18 and age > 80
  • pregnant
  • critical illness
  • drug abuse

Sites / Locations

  • Sorlandet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Multifactorial intervention

Control

Arm Description

Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin

no intervention

Outcomes

Primary Outcome Measures

New cardiovascular events (MACE)

Secondary Outcome Measures

Full Information

First Posted
July 5, 2007
Last Updated
March 16, 2021
Sponsor
Sorlandet Hospital HF
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00679237
Brief Title
Risk Reduction in Coronary Heart Disease
Acronym
SPREK!
Official Title
Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifactorial intervention
Arm Type
Active Comparator
Arm Description
Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin
Arm Title
Control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation
Intervention Description
NRT and varenicline
Intervention Type
Drug
Intervention Name(s)
betablocker, diuretics, ACEI, ARB,
Intervention Description
blood pressure control according to ESC guidelines
Intervention Type
Drug
Intervention Name(s)
statins, ezetimibe
Intervention Description
Cholesterol reduction according to ESC guidelines
Intervention Type
Behavioral
Intervention Name(s)
training
Intervention Description
daily walking
Intervention Type
Biological
Intervention Name(s)
influenza vaccine
Intervention Description
vaccine (FLuarix, Influvac etc)
Intervention Type
Drug
Intervention Name(s)
metformin, glimepiride, insulin
Intervention Description
s.glucose control according to ESC guidelines
Intervention Type
Behavioral
Intervention Name(s)
weight reduction
Intervention Description
diet tips
Primary Outcome Measure Information:
Title
New cardiovascular events (MACE)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute myocardial infarction, CABG or PCI Exclusion Criteria: Age < 18 and age > 80 pregnant critical illness drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serena Tonstad, dr.med.
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sorlandet Hospital
City
Arendal
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34915839
Citation
Kaldal A, Tonstad S, Jortveit J. Long-term hospital-based secondary prevention of coronary artery disease: a randomized controlled trial. BMC Cardiovasc Disord. 2021 Dec 16;21(1):600. doi: 10.1186/s12872-021-02426-3.
Results Reference
derived

Learn more about this trial

Risk Reduction in Coronary Heart Disease

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