Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes (80+)

Sahlgrenska University Hospital

Status and phase: Unknown; Phase 4

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

Treatments: Procedure: Coronary angiography and revascularization if feasible

Study type: Interventional

Funder types: Other

Identifiers

NCT02126202

80+

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Conservative therapy

No Intervention group

Description:

Optimized medical therapy

Invasive therapy

Experimental group

Description:

Coronary angiography and revascularization if feasible

Treatment:

Procedure: Coronary angiography and revascularization if feasible