Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis
NCT ID: NCT00811772
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
9013 participants
INTERVENTIONAL
2008-09-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bare metal stent
Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis
Percutaneous coronary intervention (PCI)
Implantation of one or more bare metal stent(s)
Drug eluting stent
Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis
Percutaneous coronary intervention (PCI)
Implantation of one or more drug eluting stent(s)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous coronary intervention (PCI)
Implantation of one or more bare metal stent(s)
Percutaneous coronary intervention (PCI)
Implantation of one or more drug eluting stent(s)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Research Council of Norway
OTHER
The Royal Norwegian Ministry of Health
OTHER
Norwegian Council on Cardiovascular diseases
UNKNOWN
University of Tromso
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kaare H Bønaa, MD, PhD
Role: 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
Role: STUDY_CHAIR
Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Medicine, Sørlandet sykehus Arendal
Arendal, , Norway
Department of Heart Disease, Haukeland University Hospital
Bergen, , Norway
Department of Heart Disease, Feiringklinikken AS
Feiring, , Norway
Department of Heart Disease, Rikshospitalet HF
Oslo, , Norway
Department of Heart and Vascular Radiology and Department of Heart Disease, Ullevål University Hospital
Oslo, , Norway
Department of Heart Disease, Stavanger University Hospital
Stavanger, , Norway
Department of Heart Disease, University Hospital of Northern Norway
Tromsø, , Norway
Department of Heart Disease, St.Olav University Hospital
Trondheim, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bonaa 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.
Samuelsen 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NSD19480
Identifier Type: -
Identifier Source: secondary_id
PREKNORD40/2008
Identifier Type: -
Identifier Source: secondary_id
184916/V50 Res. council Norway
Identifier Type: -
Identifier Source: org_study_id