Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

Angina, Unstable Clinical Trial

— 80+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126202
• Other study ID #: 80+
• Status: Recruiting
• Phase: Phase 4
• First received: January 7, 2014
• Last updated: April 27, 2014
• Start date: August 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2014
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Per A Albertsson, MD, PhD
• Phone: +46313421000
• Email: per.albertsson[@]vgregion.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Coronary angiography and revascularization if feasible
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible

Locations

Country	Name	City	State
Sweden	Department of Cardiology, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with major bleeding		1 month	Yes
Secondary	Number of participants with major adverse cardiac or cerebral event		1 month	No
Secondary	Number of participants with minor bleeding		1 month	Yes
Secondary	Number of participants with composite of cardiac death or myocardial infarction		1 year	No
Secondary	Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months		1 year	No
Secondary	Change from baseline of participants level of angina pectoris at 12 months		12 months	No
Secondary	Number of participants dead (all cause mortality)		1 year	No