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CompletedNCT02086019RINCALUpdated Jan 27, 2021

Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

An interventional study of Conservative Arm and Invasive Arm in Acute Coronary Syndromes, sponsored by Brighton and Sussex University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Brighton and Sussex University Hospitals NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
80 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Acute Coronary Syndromes

Keywords

  • Revascularisation, octogenarian,acute coronary syndromes
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 250 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • AGE>80 Non-STEMI - characteristic chest pain accompanied by
  • Typical ischaemic ECG changes
  • A troponin rise

Suitable for conservative or invasive strategy

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Other
    Conservative Arm- Medical therapy

    Medical therapy

    Drug: Conservative Arm

  • Other
    Invasive Arm-angiogram with PCI or CABG

    same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate

    Procedure: Invasive Arm

Interventions

  • DrugConservative Arm

    crossover to angiogram only if predefined criteria met

    Also known as: low molecular weight heparin,, aspirin,, clopidogrel,, beta blocker (Bisoprolol or equivalent), ACE inhibitor (Ramipril or equivalent)

  • ProcedureInvasive Arm

    angiogram with PCI or CABG revascularisation if appropriate

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 years

  2. 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

    Time frame: 1 year

  3. Major bleeding

    BARC (Bleeding Academic Research Consortium) definition

    Time frame: 1 year

  4. 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

    Time frame: During index admission

  5. Angina symptoms (3 months; 1yr)

    CCS (Canadian Cardiovascular Society Classification of angina) grading of angina

    Time frame: 3 months and 1 year

  6. Stent thrombosis

    ARC definition of stent Thrombosis

    Time frame: 1 year

  7. All cause mortality

    Cardiac and non cardiac mortality

    Time frame: 2,3 and 4 year

  8. Hospital readmission for ACS/STEMI

    ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction)

    Time frame: At 3, 6 and 12 months and at 2,3 and 4 years

  9. 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.

    Time frame: At 3, 6 and 12 months and at 2,3 and 4

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Study locations

1 site
  • Royal Sussex County Hospital
    Brighton, BN2 5BE, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02086019
Lead sponsor
Brighton and Sussex University Hospitals NHS Trust
Collaborators
Medtronic Vascular
Responsible party
Adam de Belder (Consultant Cardiologist, Brighton and Sussex University Hospitals NHS Trust) — Principal investigator
First posted
Mar 13, 2014
Start date
May 1, 2014
Primary completion
Sep 1, 2019
Completion
Dec 12, 2019
Last update
Jan 27, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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