Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

Study Overview
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Brief Summary
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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.

Official Title
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Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study

Conditions
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Angina, Unstable, Non-ST Elevation Myocardial Infarction (NSTEMI)

Intervention / Treatment
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* Procedure: Coronary angiography and revascularization if feasible


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >80 years of age 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: ST-segment depression on ECG > 1mm Elevated cardiac troponins Written informed consent before randomization Exclusion criteria: Percutaneous coronary intervention (PCI) within 30 days prior to randomization Suspected ongoing active internal bleeding ST segment elevation of >1mm in two contiguous leads on ECG Enrollment in another study that has not completed the follow up phase. Known allergy to aspirin or clopidogrel Severe dementia Expected limited 1 year survival due to other disease(s) Unwillingness to participate in the trial or expected problems with compliance

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conservative therapy<br>Optimized medical therapy | |
| Experimental: Invasive therapy<br>Coronary angiography and revascularization if feasible | Procedure: Coronary angiography and revascularization if feasible<br>* Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible<br>* Other names: Percutaneous coronary intervention (PCI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with major bleeding |  | 1 month | 
| Number of participants with major adverse cardiac or cerebral event |  | 1 month | 
| Number of participants with minor bleeding |  | 1 month | 
| Number of participants with composite of cardiac death or myocardial infarction |  | 1 year | 
| Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months |  | 1 year | 
| Change from baseline of participants level of angina pectoris at 12 months |  | 12 months | 
| Number of participants dead (all cause mortality) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Octogenarians, PCI, Myocardial infarction, NSTEMI, Unstable angina pectoris