Clinical trial NCT01255540: After Eighty Study
Official title: A Randomised Prospective Study of an Invasive Strategy Versus Medical Therapy in Patients Over 80 Years With Non ST-Elevation Myocardial Infarction (NSTEMI) or Unstable Angina Pectoris (UAP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease in patients over
80 years of age.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 492
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multicenter study

Brief summary: The rationale of the present clinical trial is to study whether an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death, reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of life. The invasive approach involves coronary angiography with immediate evaluation for three different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are commonly treated less vigorously than younger patients and the present guidelines are based on a considerably younger population.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 80 years.
* Acute coronary syndrome (NSTEMI/UAP) with chest pain \> 10 minutes, with or without ST-segment depression in ECG, and normal or elevated levels of troponin T or I. Elevated troponin levels are defined as values exceeding the 99 percentile of a normal population at the local laboratory at each participating site.
* Clinical stable

Exclusion Criteria:

* Age \< 80 years.
* ST-segment elevation in ECG (STEMI)
* Clinical unstable with ongoing chest pain or other ischaemic symptoms/signs.
* Cardiogenic shock.
* Short life expectancy due to extra cardiac reason, ie. COPD, disseminated malignant disease, or other reason.
* Anamnestic indications for significant mental disorder, including dementia.
* Any condition which interferes with patients possibility to comply with protocol.

Primary outcomes:
measure: Composite endpoints.
timeFrame: One year follow up.
Secondary outcomes:
measure: Death of any cause
timeFrame: One year from randomization
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
References:
citation: Tegn N, Eek C, Abdelnoor M, Aaberge L, Endresen K, Skardal R, Berg ES, Gullestad L, Bendz B. Patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris randomised to an invasive versus conservative strategy: angiographic and procedural results from the After Eighty study. Open Heart. 2020 Jul;7(2):e001256. doi: 10.1136/openhrt-2020-001256.
citation: Tegn N, Abdelnoor M, Aaberge L, Hylen Ranhoff A, Endresen K, Gjertsen E, Skardal R, Gullestad L, Bendz B; After Eighty study investigators. Health-related quality of life in older patients with acute coronary syndrome randomised to an invasive or conservative strategy. The After Eighty randomised controlled trial. Age Ageing. 2018 Jan 1;47(1):42-47. doi: 10.1093/ageing/afx121.
citation: Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.