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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02126202
Other study ID # 80+
Secondary ID
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


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
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