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OpenTrials
Completed

NCT Number: NCT02086019

Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

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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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Conservative Arm

Drug

crossover to angiogram only if predefined criteria met

Other names: low molecular weight heparin,, aspirin,, clopidogrel,, beta blocker (Bisoprolol or equivalent), ACE inhibitor (Ramipril or equivalent)

Invasive Arm

Procedure

angiogram with PCI or CABG revascularisation if appropriate

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Unplanned revascularisation

    Time frame: 1 years

    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.

  2. Permanent Stroke

    Time frame: 1 year

    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

  3. Major bleeding

    Time frame: 1 year

    BARC (Bleeding Academic Research Consortium) definition

  4. Deterioration of renal function during hospital admission

    Time frame: During index 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

  5. Angina symptoms (3 months; 1yr)

    Time frame: 3 months and 1 year

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

  6. Stent thrombosis

    Time frame: 1 year

    ARC definition of stent Thrombosis

  7. All cause mortality

    Time frame: 2,3 and 4 year

    Cardiac and non cardiac mortality

  8. Hospital readmission for ACS/STEMI

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

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

  9. In-hospital major complications

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

    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.

Sponsors and collaborators

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust

Other

Collaborators

  • Medtronic Vascular

Registry information

Official study title

A Prospective Randomised Controlled Trial

Acronym: RINCAL

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2014
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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