Non-ST Elevation Myocardial Infarction (NSTEMI)Phase 480+NCT02126202
Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes
A Phase 4 study testing Coronary angiography and revascularization if feasible in people with Non-ST Elevation Myocardial Infarction (NSTEMI) and Angina, Unstable, run by Sahlgrenska University Hospital at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction (NSTEMI), Angina, Unstable
- What is being tested?
- Coronary angiography and revascularization if feasible
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Cardiology, Sahlgrenska University Hospital
Gothenburg, 41345
Berglind Libungan, MD, +46313421000, berglind.libungan@vgregion.se
About this study
Official title: Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study
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.
- Being tested
- Coronary angiography and revascularization if feasible
- Keywords
- Elderly, Octogenarians, PCI, Myocardial infarction, NSTEMI, Unstable angina pectoris
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiography and revascularization if feasibleProcedure or surgery
Also called Percutaneous coronary intervention (PCI)
Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
| Study group | Role | What they receive |
|---|---|---|
| Conservative therapy | No intervention | Optimized medical therapy |
| Invasive therapy | Experimental | Coronary angiography and revascularization if feasible Receives: Procedure: Coronary angiography and revascularization if feasible |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (7)
Number of participants with major bleeding
Measured: 1 month
Number of participants with major adverse cardiac or cerebral event
Measured: 1 month
Number of participants with minor bleeding
Measured: 1 month
Number of participants with composite of cardiac death or myocardial infarction
Measured: 1 year
Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months
Measured: 1 year
Change from baseline of participants level of angina pectoris at 12 months
Measured: 12 months
Number of participants dead (all cause mortality)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startAug 2009
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-ST Elevation Myocardial Infarction (NSTEMI)Studies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Albertsson, Sahlgrenska University Hospital
- Investigators
- Per A Albertsson, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126202
- Sponsor's protocol ID
- 80+
- Acronym
- 80+
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32586153Libungan 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.
PubMed 25189626
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study
- ClinicalTrials.gov ID
- NCT02126202
- Acronym / sponsor ID
- 80+ / 80+
- Keywords
- Elderly, Octogenarians, PCI, Myocardial infarction, NSTEMI, Unstable angina pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative therapy | No intervention | –Optimized medical therapy |
| Invasive therapy | Experimental | Procedure: Coronary angiography and revascularization if feasibleCoronary angiography and revascularization if feasible |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- >80 years of age
- Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours.
- Written informed consent before randomization
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiography and revascularization if feasibleAlso: Percutaneous coronary intervention (PCI)Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible | Procedure or surgery | Invasive therapy |
Primary outcome
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).
Time frame: 1 year
7 secondary outcomes
Number of participants with major bleeding
Time frame: 1 month
Number of participants with major adverse cardiac or cerebral event
Time frame: 1 month
Number of participants with minor bleeding
Time frame: 1 month
Number of participants with composite of cardiac death or myocardial infarction
Time frame: 1 year
Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months
Time frame: 1 year
Change from baseline of participants level of angina pectoris at 12 months
Time frame: 12 months
Number of participants dead (all cause mortality)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Derived from this study: PubMed 32586153Hirlekar 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.
- Derived from this study: PubMed 25189626Libungan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per A Albertsson, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronary angiography and revascularization if feasible in people with Non-ST Elevation Myocardial Infarction (NSTEMI) and Angina, Unstable, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per A Albertsson, MD, PhD (+46313421000, per.albertsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126202, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.