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

A Prospective Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Drug: Conservative Arm; Procedure: Invasive Arm

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conservative Arm- Medical therapy; Medical therapy	Drug: Conservative Arm; 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)
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; angiogram with PCI or CABG revascularisation if appropriate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 years
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	1 year
Major bleeding	BARC (Bleeding Academic Research Consortium) definition	1 year
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	During index admission
Angina symptoms (3 months; 1yr)	CCS (Canadian Cardiovascular Society Classification of angina) grading of angina	3 months and 1 year
Stent thrombosis	ARC definition of stent Thrombosis	1 year
All cause mortality	Cardiac and non cardiac mortality	2,3 and 4 year
Hospital readmission for ACS/STEMI	ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction)	At 3, 6 and 12 months and at 2,3 and 4 years
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.	At 3, 6 and 12 months and at 2,3 and 4

Collaborators and Investigators

• Sponsor: Brighton and Sussex University Hospitals NHS Trust
• Collaborators: Medtronic Vascular

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Revascularisation, octogenarian,acute coronary syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Anticoagulants; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Clopidogrel; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Bisoprolol; Ramipril; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: BN-AdB-RINCAL-2013