Coronary AtherosclerosisNORSTENTNCT00811772
Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis
A study testing Percutaneous coronary intervention (PCI) in people with Coronary Atherosclerosis and Angina Pectoris, run by University of Tromso at 8 sites in Norway.
Trial summary
Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Atherosclerosis, Angina Pectoris, Myocardial Infarction
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,013 participants
- Where
- 8 sitesNorway
- Study dates
- Sep 2008to Dec 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women >18 years with stable angina pectoris or acute coronary syndrome
- The patient has consented to participate and has signed the patient informed consent form
- All lesions requiring intervention in one or more native coronary artery/coronary artery by-pass graft are amendable for implantation of drug-eluting stents only, or bare-metal stents only.
- The patient has a unique 11-digit Norwegian person number, is able to communicate in Norwegian, and is expected not to emigrate during study follow-up.
Who cannot join
- Previous implantation of a coronary bare metal stent or coronary drug eluting stent
- Planned intervention of a bifurcation lesion with overlapping 2-stent technique
- The patient has a serious medical condition (other than coronary artery disease) with a life expectancy less than 5 years
- The patient is currently participating in another randomized trial that clinically interferes with the present trial, or requires coronary angiography or other coronary artery imaging procedures
- Hypersensitivity or allergies to drugs or components in use with percutaneous coronary intervention
- Contraindications for treatment with clopidogrel/ticlid for 9-12 months
- Patient is receiving chronic anticoagulation therapy (e.g., warfarin, heparin)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Department of Medicine, Sørlandet sykehus Arendal
Arendal, N-4838
Department of Heart Disease, Haukeland University Hospital
Bergen, N-5053 Bergen
Department of Heart Disease, Feiringklinikken AS
Feiring, N-2093
Department of Heart Disease, Rikshospitalet HF
Oslo, N-0027
Department of Heart and Vascular Radiology and Department of Heart Disease, Ullevål University Hospital
Oslo, N-0450
Department of Heart Disease, Stavanger University Hospital
Stavanger, N-4068
Department of Heart Disease, University Hospital of Northern Norway
Tromsø, N-9038
Department of Heart Disease, St.Olav University Hospital
Trondheim, N-7006
About this study
Official title: Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES.
The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.
Read the detailed description
Background:
The balance of the long-term risks and benefits of coronary drug-eluting stents versus bare metal stents is not known.
Study objective:
The primary objective of the trial is to compare in a real-world setting the long-term effects on the incidence of death and myocardial infarction (composite primary end-point) after implantation of drug-eluting stents versus bare-metal stents. The secondary objective is to compare the long-term effects on the incidence of total death, cardiovascular deaths, major cardiovascular events, angina pectoris, revascularization procedures, and on health-related quality of life after implantation of drug-eluting stents versus bare-metal stents. The main tertiary objective is to assess the safety and efficacy in patient subgroups with specific demographic, clinical, and vessel- or lesion characteristics, and to conduct a cost-effectiveness analysis.
Study design:
This is a randomized, five-year prospective, multicenter, open-label clinical trial with blinded end point-evaluation.
Setting:
Investigator initiated trial conducted at 8 Norwegian interventional centres. The trial is sponsored by the Norwegian Research Council, the Regional Health Authorities and other not-for-profit organizations.
Randomization:
Patients will be randomized to receive either drug-eluting stent(s) or a bare-metal stent(s) in a 1:1 ratio.
Patients:
The trial will include 9000 patients with de novo lesions in native coronary arteries or by-pass grafts who meet the eligibility criteria. Men and women with stable angina pectoris or acute coronary syndrome will be included.
End-point:
The primary composite end point is total death and nonfatal myocardial infarction.Secondary end-points include total death and subcategories of death, fatal and nonfatal myocardial infarction, fatal and nonfatal stroke, angina pectoris, revascularization, major bleeding, health-related quality of life.
Length of follow-up:
Five years.
End-points collected by electronic linkage to national registries:
The trial will use the unique Norwegian 11-digit person number to search the National Patient Registry and the National Death Registry for nonfatal and fatal end-points during follow-up, thereby minimizing loss to follow-up. Information on angina pectoris and health-related quality of life will be collected by questionnaires.
Statistical power:
The trial has a statistical power of 93 percent to detect a three percent (RR 1.176) absolute difference in incidence between the study groups, and a power of 64 percent to detect a two percent (RR 1.118) absolute difference, given a two-sided alpha value of 0.05.
Statistical analysis:
Statistical analyses will be conducted according to the intention-to-treat principle, and will be performed by using widely accepted statistical and/or graphical software.
Data collection:
Electronic Case Record Form (e-CRF)
Clinical Event Committee:
Adjudication of all end-points according to pre-specified and standardized criteria by Clinical Event Committee blinded to study assignment.
Expected Timelines:
First patient enrollment: September 2008 Last patient enrollment: February 2011 Completion of Follow-up: December 2014.
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- Randomized controlled trial, Bare metal stent, Drug eluting stent
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Device
Implantation of one or more bare metal stent(s)
Percutaneous coronary intervention (PCI)Device
Implantation of one or more drug eluting stent(s)
| Study group | Role | What they receive |
|---|---|---|
| Bare metal stent | Active comparator | Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis Receives: Device: Percutaneous coronary intervention (PCI) |
| Drug eluting stent | Experimental | Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis Receives: Device: Percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of all-cause mortality and non-fatal myocardial infarction (composite)
Measured: After five years of follow-up
Secondary outcomes (2)
Major cardiovascular events
Measured: After five years of follow-up
Health related quality of life
Measured: After 6 months and then yearly for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary AtherosclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, The Royal Norwegian Ministry of Health, Norwegian Council on Cardiovascular diseases
- Responsible party
- Sponsor
- Investigators
- Kaare H Bønaa, MD, PhD, Principal investigator, Dept of Heart Disease, St.Olavs University Hospital, Trondheim, Norway; Norwegian University of Science and Technology, Trondheim, Norway; University of Tromsø, Tromsø, NorwayJan E Nordrehaug, MD, PhD, Study chair, Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811772
- Sponsor's protocol ID
- 184916/V50 Res. council Norway
- Other IDs
- NSD19480, PREKNORD40/2008
- Acronym
- NORSTENT
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2008
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Nordrehaug JE, Wiseth R, Bonaa KH. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Dec 29;375(26):2604-2605. doi: 10.1056/NEJMc1613866. No abstract available.
PubMed 28029911Bonaa KH, Mannsverk J, Wiseth R, Aaberge L, Myreng Y, Nygard O, Nilsen DW, Klow NE, Uchto M, Trovik T, Bendz B, Stavnes S, Bjornerheim R, Larsen AI, Slette M, Steigen T, Jakobsen OJ, Bleie O, Fossum E, Hanssen TA, Dahl-Eriksen O, Njolstad I, Rasmussen K, Wilsgaard T, Nordrehaug JE; NORSTENT Investigators. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Sep 29;375(13):1242-52. doi: 10.1056/NEJMoa1607991. Epub 2016 Aug 29.
PubMed 27572953Samuelsen PJ, Eggen AE, Steigen T, Wilsgaard T, Kristensen A, Skogsholm A, Holme E, van den Heuvel C, Nordrehaug JE, Bendz B, Nilsen DWT, Bonaa KH. Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT). PLoS One. 2021 Mar 4;16(3):e0247358. doi: 10.1371/journal.pone.0247358. eCollection 2021.
PubMed 33661918
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT00811772
- Acronym / sponsor ID
- NORSTENT / 184916/V50 Res. council Norway
- Keywords
- Randomized controlled trial, Bare metal stent, Drug eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,013 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- The Research Council of Norway, The Royal Norwegian Ministry of Health, Norwegian Council on Cardiovascular diseases
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Dec 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.
Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES.
The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.
Detailed description
Background:
The balance of the long-term risks and benefits of coronary drug-eluting stents versus bare metal stents is not known.
Study objective:
The primary objective of the trial is to compare in a real-world setting the long-term effects on the incidence of death and myocardial infarction (composite primary end-point) after implantation of drug-eluting stents versus bare-metal stents. The secondary objective is to compare the long-term effects on the incidence of total death, cardiovascular deaths, major cardiovascular events, angina pectoris, revascularization procedures, and on health-related quality of life after implantation of drug-eluting stents versus bare-metal stents. The main tertiary objective is to assess the safety and efficacy in patient subgroups with specific demographic, clinical, and vessel- or lesion characteristics, and to conduct a cost-effectiveness analysis.
Study design:
This is a randomized, five-year prospective, multicenter, open-label clinical trial with blinded end point-evaluation.
Setting:
Investigator initiated trial conducted at 8 Norwegian interventional centres. The trial is sponsored by the Norwegian Research Council, the Regional Health Authorities and other not-for-profit organizations.
Randomization:
Patients will be randomized to receive either drug-eluting stent(s) or a bare-metal stent(s) in a 1:1 ratio.
Patients:
The trial will include 9000 patients with de novo lesions in native coronary arteries or by-pass grafts who meet the eligibility criteria. Men and women with stable angina pectoris or acute coronary syndrome will be included.
End-point:
The primary composite end point is total death and nonfatal myocardial infarction.Secondary end-points include total death and subcategories of death, fatal and nonfatal myocardial infarction, fatal and nonfatal stroke, angina pectoris, revascularization, major bleeding, health-related quality of life.
Length of follow-up:
Five years.
End-points collected by electronic linkage to national registries:
The trial will use the unique Norwegian 11-digit person number to search the National Patient Registry and the National Death Registry for nonfatal and fatal end-points during follow-up, thereby minimizing loss to follow-up. Information on angina pectoris and health-related quality of life will be collected by questionnaires.
Statistical power:
The trial has a statistical power of 93 percent to detect a three percent (RR 1.176) absolute difference in incidence between the study groups, and a power of 64 percent to detect a two percent (RR 1.118) absolute difference, given a two-sided alpha value of 0.05.
Statistical analysis:
Statistical analyses will be conducted according to the intention-to-treat principle, and will be performed by using widely accepted statistical and/or graphical software.
Data collection:
Electronic Case Record Form (e-CRF)
Clinical Event Committee:
Adjudication of all end-points according to pre-specified and standardized criteria by Clinical Event Committee blinded to study assignment.
Expected Timelines:
First patient enrollment: September 2008 Last patient enrollment: February 2011 Completion of Follow-up: December 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bare metal stent | Active comparator | Device: Percutaneous coronary intervention (PCI)Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis |
| Drug eluting stent | Experimental | Device: Percutaneous coronary intervention (PCI)Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women >18 years with stable angina pectoris or acute coronary syndrome
- The patient has consented to participate and has signed the patient informed consent form
- All lesions requiring intervention in one or more native coronary artery/coronary artery by-pass graft are amendable for implantation of drug-eluting stents only, or bare-metal stents only.
- The patient has a unique 11-digit Norwegian person number, is able to communicate in Norwegian, and is expected not to emigrate during study follow-up.
Key exclusion criteria (7 listed)
- Previous implantation of a coronary bare metal stent or coronary drug eluting stent
- Planned intervention of a bifurcation lesion with overlapping 2-stent technique
- The patient has a serious medical condition (other than coronary artery disease) with a life expectancy less than 5 years
- The patient is currently participating in another randomized trial that clinically interferes with the present trial, or requires coronary angiography or other coronary artery imaging procedures
- Hypersensitivity or allergies to drugs or components in use with percutaneous coronary intervention
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 |
|---|---|---|
| Percutaneous coronary intervention (PCI)Implantation of one or more bare metal stent(s) | Device | Bare metal stent |
| Percutaneous coronary intervention (PCI)Implantation of one or more drug eluting stent(s) | Device | Drug eluting stent |
Primary outcome
First occurrence of all-cause mortality and non-fatal myocardial infarction (composite)
Time frame: After five years of follow-up
2 secondary outcomes
Major cardiovascular events
Time frame: After five years of follow-up
Health related quality of life
Time frame: After 6 months and then yearly for 5 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 24 Dec 2018.
- Background: PubMed 28029911Nordrehaug JE, Wiseth R, Bonaa KH. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Dec 29;375(26):2604-2605. doi: 10.1056/NEJMc1613866. No abstract available.
- Results publication: PubMed 27572953Bonaa KH, Mannsverk J, Wiseth R, Aaberge L, Myreng Y, Nygard O, Nilsen DW, Klow NE, Uchto M, Trovik T, Bendz B, Stavnes S, Bjornerheim R, Larsen AI, Slette M, Steigen T, Jakobsen OJ, Bleie O, Fossum E, Hanssen TA, Dahl-Eriksen O, Njolstad I, Rasmussen K, Wilsgaard T, Nordrehaug JE; NORSTENT Investigators. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Sep 29;375(13):1242-52. doi: 10.1056/NEJMoa1607991. Epub 2016 Aug 29.
- Derived from this study: PubMed 33661918Samuelsen PJ, Eggen AE, Steigen T, Wilsgaard T, Kristensen A, Skogsholm A, Holme E, van den Heuvel C, Nordrehaug JE, Bendz B, Nilsen DWT, Bonaa KH. Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT). PLoS One. 2021 Mar 4;16(3):e0247358. doi: 10.1371/journal.pone.0247358. eCollection 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Atherosclerosis
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Kaare H Bønaa, MD, PhD principal investigator
Dept of Heart Disease, St.Olavs University Hospital, Trondheim, Norway; Norwegian University of Science and Technology, Trondheim, Norway; University of Tromsø, Tromsø, Norway
Jan E Nordrehaug, MD, PhD study chair
Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI) in people with Coronary Atherosclerosis and Angina Pectoris, run by University of Tromso at 8 sites 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 4 inclusion and 7 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) (time frame: After five years of follow-up). 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 NCT00811772, which also lists 3 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 24 Dec 2018.