Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

NCT02086019 | Completed DMC

• 1 other identifier: BN-AdB-RINCAL-2013
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndromes

Keywords

Revascularisation, octogenarian,acute coronary syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 year

Secondary Outcomes (9)

• Unplanned revascularisation

  1 years

• Permanent Stroke

  1 year

• Major bleeding

  1 year

• Deterioration of renal function during hospital admission

  During index admission

• Angina symptoms (3 months; 1yr)

  3 months and 1 year

Study Arms (2)

Conservative Arm- Medical therapy

OTHER

Medical therapy

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

Procedure: Invasive Arm

Interventions

Conservative Arm DRUG

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)

Conservative Arm- Medical therapy

Invasive Arm PROCEDURE

angiogram with PCI or CABG revascularisation if appropriate

Invasive Arm-angiogram with PCI or CABG

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• AGE\>80 Non-STEMI - characteristic chest pain accompanied by
• Typical ischaemic ECG changes
• A troponin rise
• Suitable for conservative or invasive strategy

You may not qualify if:

• 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

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead
• Medtronic Vascular: collaborator

Study Sites (1)

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Heparin, Low-Molecular-Weight; Aspirin; Clopidogrel; Adrenergic beta-Antagonists; Bisoprolol; Angiotensin-Converting Enzyme Inhibitors; Ramipril

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Protease Inhibitors; Enzyme Inhibitors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: December 12, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

GB (1)