Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis (NORSTENT)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Tromso
Collaborators:
The Research Council of Norway
The Royal Norwegian Ministry of Health
Norwegian Council on Cardiovascular diseases
Information provided by:
University of Tromso
ClinicalTrials.gov Identifier:
NCT00811772
First received: December 18, 2008
Last updated: May 19, 2011
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Atherosclerosis Angina Pectoris Myocardial Infarction |
Device: Percutaneous coronary intervention (PCI) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Angina
Atherosclerosis
Coronary Artery Disease
Heart Attack
Heart Diseases
U.S. FDA Resources
Further study details as provided by University of Tromso:
Primary Outcome Measures:
- First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) [ Time Frame: After five years of follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Major cardiovascular events [ Time Frame: After five years of follow-up ] [ Designated as safety issue: Yes ]
- Health related quality of life [ Time Frame: After 6 months and then yearly for 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 9000 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bare metal stent
Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis
|
Device: Percutaneous coronary intervention (PCI)
Implantation of one or more bare metal stent(s)
|
|
Experimental: Drug eluting stent
Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis
|
Device: Percutaneous coronary intervention (PCI)
Implantation of one or more drug eluting stent(s)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811772
Locations
| Norway | |
| Department of Medicine, Sørlandet sykehus Arendal | |
| Arendal, Norway, N-4838 | |
| Department of Heart Disease, Haukeland University Hospital | |
| Bergen, Norway, N-5053 Bergen | |
| Department of Heart Disease, Feiringklinikken AS | |
| Feiring, Norway, N-2093 | |
| Department of Heart and Vascular Radiology and Department of Heart Disease, Ullevål University Hospital | |
| Oslo, Norway, N-0450 | |
| Department of Heart Disease, Rikshospitalet HF | |
| Oslo, Norway, N-0027 | |
| Department of Heart Disease, Stavanger University Hospital | |
| Stavanger, Norway, N-4068 | |
| Department of Heart Disease, University Hospital of Northern Norway | |
| Tromsø, Norway, N-9038 | |
| Department of Heart Disease, St.Olav University Hospital | |
| Trondheim, Norway, N-7006 | |
Sponsors and Collaborators
University of Tromso
The Research Council of Norway
The Royal Norwegian Ministry of Health
Norwegian Council on Cardiovascular diseases
Investigators
| Principal Investigator: | Kaare H Bønaa, MD, PhD | Dept of Heart Disease, St.Olavs University Hospital, Trondheim, Norway; Norwegian University of Science and Technology, Trondheim, Norway; University of Tromsø, Tromsø, Norway |
| Study Chair: | Jan E Nordrehaug, MD, PhD | Department of Heart Disease, Haukeland University Hospital, Bergen, and University of Bergen, Bergen, Norway |
More Information
No publications provided
| Responsible Party: | Kaare Harald Bønaa, University of Tromsø, Tromsø, Norway |
| ClinicalTrials.gov Identifier: | NCT00811772 History of Changes |
| Other Study ID Numbers: | 184916/V50 Res. council Norway, NSD19480, PREKNORD40/2008 |
| Study First Received: | December 18, 2008 |
| Last Updated: | May 19, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services |
Keywords provided by University of Tromso:
|
Randomized controlled trial Bare metal stent Drug eluting stent |
Additional relevant MeSH terms:
|
Angina Pectoris Atherosclerosis Coronary Artery Disease Myocardial Ischemia Infarction Myocardial Infarction Coronary Stenosis Heart Diseases Cardiovascular Diseases Vascular Diseases |
Chest Pain Pain Signs and Symptoms Arteriosclerosis Arterial Occlusive Diseases Coronary Disease Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 23, 2013