Acute Coronary SyndromesRINCALNCT02086019
Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes
A study testing Conservative Arm and Invasive Arm in people with Acute Coronary Syndromes, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Conservative Arm and Invasive Arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2014to 12 Dec 2019
- Phase
- Interventional
- 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
- AGE>80 Non-STEMI - characteristic chest pain accompanied by
- Typical ischaemic ECG changes
- A troponin rise
- Suitable for conservative or invasive strategy
Who cannot join
- Lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity
- Acute STEMI
- Cardiogenic shock
- Platelet count =50 x 109/mm3
- Patient life expectancy < 1 year
- Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
Show all 11Show fewer
- Recent major GI haemorrhage (within 3 months)
- Any previous cerebral bleeding episode
- Participation in another investigational drug or device study
- Patient unable to give consent
- Clinical decision precluding the use of stents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Controlled Trial
For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Conservative Arm, Invasive Arm
- Keywords
- Revascularisation, octogenarian,acute coronary syndromes
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative ArmDrug
Also called low molecular weight heparin,, aspirin,, clopidogrel,, beta blocker (Bisoprolol or equivalent)
crossover to angiogram only if predefined criteria met
Invasive ArmProcedure or surgery
angiogram with PCI or CABG revascularisation if appropriate
| Study group | Role | What they receive |
|---|---|---|
| Conservative Arm- Medical therapy | Other | Medical therapy Receives: Drug: Conservative Arm |
| Invasive Arm-angiogram with PCI or CABG | Other | same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate Receives: Procedure: Invasive Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The cause of death will be adjudicated as being due to cardiovascular causes, non cardiovascular causes, or undetermined causes.
- Cardiovascular Death includes sudden cardiac death, death due to acute myocardial infarction, death due to heart failure or cardiogenic shock, death due to stroke or death due to other cardiovascular causes
- Non-Cardiovascular Death is defined as any death not covered by cardiac death or vascular death.
- Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a non-cardiovascular cause.
N.B For this trial all deaths with undetermined causes will be included in the cardiovascular category.
Measured: 1 year
non-fatal myocardial infarction
The ESC/ACC (European Society of Cardiology and the American College of Cardiology) definition of myocardial infarction will be applied, including the special circumstances of same admission myocardial re-infarction, or myocardial infarction peri-PCI.
Measured: 1 year
Secondary outcomes (9)
Unplanned revascularisation
Shall be deemed to have occurred at follow-up if any coronary vessel requires or undergoes attempted repeat revascularisation with either balloon angioplasty, stenting, or coronary artery bypass grafting.
Measured: 1 years
Permanent Stroke
A stroke is a loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death
Measured: 1 year
Major bleeding
BARC (Bleeding Academic Research Consortium) definition
Measured: 1 year
Deterioration of renal function during hospital admission
Worsening renal function is an absolute increase in serum creatinine of ≥ 0.3mg/dl (26.5 umol/l) at any time during hospitalization compared to the valve obtained at admission
Measured: During index admission
Angina symptoms (3 months; 1yr)
CCS (Canadian Cardiovascular Society Classification of angina) grading of angina
Measured: 3 months and 1 year
Stent thrombosis
ARC definition of stent Thrombosis
Measured: 1 year
All cause mortality
Cardiac and non cardiac mortality
Measured: 2,3 and 4 year
Hospital readmission for ACS/STEMI
ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction)
Measured: At 3, 6 and 12 months and at 2,3 and 4 years
In-hospital major complications
In hospital major complications defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke.
Measured: At 3, 6 and 12 months and at 2,3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start1 May 2014
- Primary completion1 Sep 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Vascular
- Responsible party
- Principal investigator, Adam de Belder, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086019
- Sponsor's protocol ID
- BN-AdB-RINCAL-2013
- Acronym
- RINCAL
- Status last verified
- Jan 2021
- First submitted
- 4 Mar 2014
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02086019
- Acronym / sponsor ID
- RINCAL / BN-AdB-RINCAL-2013
- Conditions
- Acute Coronary Syndromes
- Keywords
- Revascularisation, octogenarian,acute coronary syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic Vascular
- Study start
- 1 May 2014
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 13 Mar 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.
For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Arm- Medical therapy | Other | Drug: Conservative ArmMedical therapy |
| Invasive Arm-angiogram with PCI or CABG | Other | Procedure: Invasive Armsame medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- AGE>80 Non-STEMI - characteristic chest pain accompanied by
- Typical ischaemic ECG changes
- A troponin rise
- Suitable for conservative or invasive strategy
Key exclusion criteria (11 listed)
- Lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity
- Acute STEMI
- Cardiogenic shock
- Platelet count =50 x 109/mm3
- Patient life expectancy < 1 year
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 |
|---|---|---|
| Conservative ArmAlso: low molecular weight heparin,, aspirin,, clopidogrel,, beta blocker (Bisoprolol or equivalent)crossover to angiogram only if predefined criteria met | Drug | Conservative Arm- Medical therapy |
| Invasive Armangiogram with PCI or CABG revascularisation if appropriate | Procedure or surgery | Invasive Arm-angiogram with PCI or CABG |
Primary outcome
Death
Time frame: 1 year
The cause of death will be adjudicated as being due to cardiovascular causes, non cardiovascular causes, or undetermined causes. * Cardiovascular Death includes sudden cardiac death, death due to acute myocardial infarction, death due to heart failure or cardiogenic shock, death due to stroke or death due to other cardiovascular causes * Non-Cardiovascular Death is defined as any death not covered by cardiac death or vascular death. * Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a non-cardiovascular cause. N.B For this trial all deaths with undetermined causes will be included in the cardiovascular category.
non-fatal myocardial infarction
Time frame: 1 year
The ESC/ACC (European Society of Cardiology and the American College of Cardiology) definition of myocardial infarction will be applied, including the special circumstances of same admission myocardial re-infarction, or myocardial infarction peri-PCI.
9 secondary outcomes
Unplanned revascularisation
Time frame: 1 years
Permanent Stroke
Time frame: 1 year
Major bleeding
Time frame: 1 year
Deterioration of renal function during hospital admission
Time frame: During index admission
Angina symptoms (3 months; 1yr)
Time frame: 3 months and 1 year
Stent thrombosis
Time frame: 1 year
All cause mortality
Time frame: 2,3 and 4 year
Hospital readmission for ACS/STEMI
Time frame: At 3, 6 and 12 months and at 2,3 and 4 years
In-hospital major complications
Time frame: At 3, 6 and 12 months and at 2,3 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative Arm and Invasive Arm in people with Acute Coronary Syndromes, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.