Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes
NCT ID: NCT02126202
Last Updated: 2014-04-29
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
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2009-08-31
2016-01-31
Brief Summary
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A total of 200 patients will be randomized to medical treatment (100 patients) or coronary angiography with revascularization if feasible (100 patients). Information regarding prior history, frailty, clinical presentation, in-hospital events, complications, angina, quality of life and mortality will be collected. Follow up time is 1 year.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conservative therapy
Optimized medical therapy
No interventions assigned to this group
Invasive therapy
Coronary angiography and revascularization if feasible
Coronary angiography and revascularization if feasible
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
Interventions
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Coronary angiography and revascularization if feasible
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours.
AND at least one of the following:
1. ST-segment depression on ECG \> 1mm
2. Elevated cardiac troponins
3. Written informed consent before randomization
Exclusion Criteria
2. Suspected ongoing active internal bleeding
3. ST segment elevation of \>1mm in two contiguous leads on ECG
4. Enrollment in another study that has not completed the follow up phase.
5. Known allergy to aspirin or clopidogrel
6. Severe dementia
7. Expected limited 1 year survival due to other disease(s)
8. Unwillingness to participate in the trial or expected problems with compliance
80 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Per Albertsson
Head of Cardiology
Principal Investigators
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Per A Albertsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Department of Cardiology, Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Hirlekar G, Libungan B, Karlsson T, Back M, Herlitz J, Albertsson P. Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study. Scand Cardiovasc J. 2020 Oct;54(5):315-321. doi: 10.1080/14017431.2020.1781243. Epub 2020 Jun 26.
Libungan B, Hirlekar G, Albertsson P. Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:349. doi: 10.1186/1745-6215-15-349.
Other Identifiers
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80+
Identifier Type: -
Identifier Source: org_study_id
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