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After Eighty Study

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01255540
Enrollment
492
Registered
2010-12-07
Start date
2010-12-31
Completion date
2019-02-28
Last updated
2015-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Coronary heart disease in patients over, 80 years of age.

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.

Interventions

None listed

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Composite endpoints.One year follow up.Does an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP improve rates of death, reinfarction, stroke and need of urgent revascularisation?

Secondary

MeasureTime frame
Death of any causeOne year from randomization

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026