Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes (RINCAL)

Brighton and Sussex University Hospitals NHS Trust

Status: Completed

Conditions: Acute Coronary Syndromes

Treatments: Drug: Conservative Arm; Procedure: Invasive Arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02086019

BN-AdB-RINCAL-2013

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Conservative Arm- Medical therapy

Other group

Description:

Medical therapy

Treatment:

Drug: Conservative Arm

Invasive Arm-angiogram with PCI or CABG

Other group

Description:

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

Treatment:

Procedure: Invasive Arm