Coronary Heart DiseaseSPREK!NCT00679237
Risk Reduction in Coronary Heart Disease
A study testing smoking cessation, betablocker, diuretics, ACEI, ARB, and statins, ezetimibe in people with Coronary Heart Disease, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- smoking cessation, betablocker, diuretics, ACEI, ARB, and statins, ezetimibe
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2007to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myocardial infarction, CABG or PCI
Who cannot join
- Age < 18 and age > 80
- pregnant
- critical illness
- drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death
- Conditions
- Coronary Heart Disease
- Being tested
- smoking cessation, betablocker, diuretics, ACEI, ARB,, statins, ezetimibe, training, influenza vaccine
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessationBehavioural
NRT and varenicline
betablocker, diuretics, ACEI, ARB,Drug
blood pressure control according to ESC guidelines
statins, ezetimibeDrug
Cholesterol reduction according to ESC guidelines
trainingBehavioural
daily walking
influenza vaccineBiological
vaccine (FLuarix, Influvac etc)
metformin, glimepiride, insulinDrug
s.glucose control according to ESC guidelines
weight reductionBehavioural
diet tips
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial intervention | Active comparator | Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin Receives: Behavioral: smoking cessation; Drug: betablocker, diuretics, ACEI, ARB,; Drug: statins, ezetimibe; Behavioral: training; Biological: influenza vaccine; Drug: metformin, glimepiride, insulin; Behavioral: weight reduction |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
New cardiovascular events (MACE)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Sissel Ledang, Sorlandet Hospital HF
- Investigators
- Serena Tonstad, dr.med., Study chair, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679237
- Sponsor's protocol ID
- S-07041a (REK)
- Acronym
- SPREK!
- Status last verified
- Mar 2021
- First submitted
- 5 Jul 2007
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaldal A, Tonstad S, Jortveit J. Self-reported smoking status and exhaled carbon monoxide in secondary preventive follow-up after coronary heart events: Do our patients tell the truth? Tob Prev Cessat. 2024 Sep 25;10. doi: 10.18332/tpc/191843. eCollection 2024.
PubMed 39323439Kaldal A, Tonstad S, Jortveit J. Sex differences in secondary preventive follow-up after coronary heart events. BMC Cardiovasc Disord. 2023 Sep 14;23(1):459. doi: 10.1186/s12872-023-03483-6.
PubMed 37710178Kaldal A, Tonstad S, Jortveit J. Association of Troponin T measurements with long-term outcomes in patients with coronary artery disease participating in a secondary prevention trial. BMC Cardiovasc Disord. 2023 Apr 28;23(1):210. doi: 10.1186/s12872-023-03249-0.
PubMed 37118703Kaldal 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.
PubMed 34915839
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00679237
- Acronym / sponsor ID
- SPREK! / S-07041a (REK)
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital
- Study start
- Sep 2007 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifactorial intervention | Active comparator | Behavioral: smoking cessation, Drug: betablocker, diuretics, ACEI, ARB,, Drug: statins, ezetimibe, Behavioral: training, Biological: influenza vaccine, Drug: metformin, glimepiride, insulin, Behavioral: weight reductionSmoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute myocardial infarction, CABG or PCI
Key exclusion criteria (4 listed)
- Age < 18 and age > 80
- pregnant
- critical illness
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking cessationNRT and varenicline | Behavioural | Multifactorial intervention |
| betablocker, diuretics, ACEI, ARB,blood pressure control according to ESC guidelines | Drug | Multifactorial intervention |
| statins, ezetimibeCholesterol reduction according to ESC guidelines | Drug | Multifactorial intervention |
| trainingdaily walking | Behavioural | Multifactorial intervention |
| influenza vaccinevaccine (FLuarix, Influvac etc) | Biological | Multifactorial intervention |
| metformin, glimepiride, insulins.glucose control according to ESC guidelines | Drug | Multifactorial intervention |
| weight reductiondiet tips | Behavioural | Multifactorial intervention |
Primary outcome
New cardiovascular events (MACE)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 39323439Kaldal A, Tonstad S, Jortveit J. Self-reported smoking status and exhaled carbon monoxide in secondary preventive follow-up after coronary heart events: Do our patients tell the truth? Tob Prev Cessat. 2024 Sep 25;10. doi: 10.18332/tpc/191843. eCollection 2024.
- Derived from this study: PubMed 37710178Kaldal A, Tonstad S, Jortveit J. Sex differences in secondary preventive follow-up after coronary heart events. BMC Cardiovasc Disord. 2023 Sep 14;23(1):459. doi: 10.1186/s12872-023-03483-6.
- Derived from this study: PubMed 37118703Kaldal A, Tonstad S, Jortveit J. Association of Troponin T measurements with long-term outcomes in patients with coronary artery disease participating in a secondary prevention trial. BMC Cardiovasc Disord. 2023 Apr 28;23(1):210. doi: 10.1186/s12872-023-03249-0.
- Derived from this study: PubMed 34915839Kaldal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serena Tonstad, dr.med. study chair
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation, betablocker, diuretics, ACEI, ARB, and statins, ezetimibe in people with Coronary Heart Disease, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New cardiovascular events (MACE) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00679237, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.