Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes

NCT ID: NCT02126202

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-01-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative therapy

Optimized medical therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Invasive therapy

Coronary angiography and revascularization if feasible

Group Type EXPERIMENTAL

Coronary angiography and revascularization if feasible

Intervention Type PROCEDURE

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

Interventions

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Coronary angiography and revascularization if feasible

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

Intervention Type PROCEDURE

Other Intervention Names

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Percutaneous coronary intervention (PCI)

Eligibility Criteria

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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
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per Albertsson

Head of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per A Albertsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Department of Cardiology, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Per A Albertsson, MD, PhD

Role: CONTACT

+46313421000

Facility Contacts

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Berglind Libungan, MD

Role: primary

+46313421000

References

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Hirlekar G, Libungan B, Karlsson T, Back M, Herlitz J, Albertsson P. Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study. Scand Cardiovasc J. 2020 Oct;54(5):315-321. doi: 10.1080/14017431.2020.1781243. Epub 2020 Jun 26.

Reference Type DERIVED
PMID: 32586153 (View on PubMed)

Libungan B, Hirlekar G, Albertsson P. Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:349. doi: 10.1186/1745-6215-15-349.

Reference Type DERIVED
PMID: 25189626 (View on PubMed)

Other Identifiers

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80+

Identifier Type: -

Identifier Source: org_study_id

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