NCT02126202

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 29, 2014

Status Verified

January 1, 2014

Enrollment Period

5.4 years

First QC Date

January 7, 2014

Last Update Submit

April 27, 2014

Conditions

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

Keywords

ElderlyOctogenariansPCIMyocardial infarctionNSTEMIUnstable angina pectoris

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Conservative therapy

NO INTERVENTION

Optimized medical therapy

Invasive therapy

EXPERIMENTAL

Coronary angiography and revascularization if feasible

Procedure: Coronary angiography and revascularization if feasible

Interventions

Coronary angiography and revascularization if feasiblePROCEDURE

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

Also known as: Percutaneous coronary intervention (PCI)
Invasive therapy

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32586153DERIVED

  • 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.

    PMID: 25189626DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial InfarctionAngina, UnstableMyocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Per A Albertsson, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per A Albertsson, MD, PhD

CONTACT

+46313421000per.albertsson@vgregion.se

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology

Study Record Dates

First Submitted

January 7, 2014

First Posted

April 29, 2014

Study Start

August 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

April 29, 2014

Record last verified: 2014-01

Locations

SE(1)