Myocardial Infarction Clinical Trial
— NORSTENTOfficial 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
Verified date | December 2018 |
Source | University of Tromso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9013 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Norway | 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 and Vascular Radiology and Department of Heart Disease, Ullevål University Hospital | Oslo | |
Norway | Department of Heart Disease, Rikshospitalet HF | 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 |
Lead Sponsor | Collaborator |
---|---|
University of Tromso | Norwegian Council on Cardiovascular diseases, The Research Council of Norway, The Royal Norwegian Ministry of Health |
Norway,
Bønaa KH, Mannsverk J, Wiseth R, Aaberge L, Myreng Y, Nygård O, Nilsen DW, Kløw NE, Uchto M, Trovik T, Bendz B, Stavnes S, Bjørnerheim R, Larsen AI, Slette M, Steigen T, Jakobsen OJ, Bleie Ø, Fossum E, Hanssen TA, Dahl-Eriksen Ø, Njølstad I, Rasmussen K, — View Citation
Nordrehaug JE, Wiseth R, Bønaa 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) | After five years of follow-up | ||
Secondary | Major cardiovascular events | After five years of follow-up | ||
Secondary | Health related quality of life | After 6 months and then yearly for 5 years |
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