Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

NCT ID: NCT02086019

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2019-12-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conservative Arm- Medical therapy

Medical therapy

Group Type: OTHER

Conservative Arm

Intervention Type: DRUG

crossover to angiogram only if predefined criteria met

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

Group Type: OTHER

Invasive Arm

Intervention Type: PROCEDURE

angiogram with PCI or CABG revascularisation if appropriate

Interventions

Conservative Arm

crossover to angiogram only if predefined criteria met

Intervention Type: DRUG

Invasive Arm

angiogram with PCI or CABG revascularisation if appropriate

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: collaborator

Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Adam de Belder

Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Royal Sussex County Hospital

Brighton, , United Kingdom

Countries

United Kingdom

Other Identifiers

BN-AdB-RINCAL-2013

Identifier Type: -

Identifier Source: org_study_id