Clinical trial NCT02126202: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes
Official title: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-ST Elevation Myocardial Infarction (NSTEMI)
Angina, Unstable
Keywords: Elderly
Octogenarians
PCI
Myocardial infarction
NSTEMI
Unstable angina pectoris
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized clinical trial in elderly patients (over 80 years old) with unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).

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.


Eligibility criteria: Inclusion Criteria:

1. \>80 years of age
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:

1. Percutaneous coronary intervention (PCI) within 30 days prior to randomization
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

Primary outcomes:
measure: Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke).
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with major bleeding
timeFrame: 1 month
measure: Number of participants with major adverse cardiac or cerebral event
timeFrame: 1 month
measure: Number of participants with minor bleeding
timeFrame: 1 month
measure: Number of participants with composite of cardiac death or myocardial infarction
timeFrame: 1 year
measure: Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months
timeFrame: 1 year
measure: Change from baseline of participants level of angina pectoris at 12 months
timeFrame: 12 months
measure: Number of participants dead (all cause mortality)
timeFrame: 1 year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Cardiology, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Per A Albertsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.