Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

Not Applicable

Completed

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: Conservative Arm; Procedure: Invasive Arm

• Registration Number: NCT02086019
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Start: 2014-05-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative Arm- Medical therapy	Conservative Arm	Medical therapy
Invasive Arm-angiogram with PCI or CABG	Invasive Arm	same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate

Primary Outcome Measures

Name	Time	Method
Death	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.
non-fatal myocardial infarction	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 Outcome Measures

Name	Time	Method
Major bleeding	1 year	BARC (Bleeding Academic Research Consortium) definition
Deterioration of renal function during hospital admission	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
In-hospital major complications	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.
Unplanned revascularisation	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.
Permanent Stroke	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
Angina symptoms (3 months; 1yr)	3 months and 1 year	CCS (Canadian Cardiovascular Society Classification of angina) grading of angina
All cause mortality	2,3 and 4 year	Cardiac and non cardiac mortality
Hospital readmission for ACS/STEMI	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)
Stent thrombosis	1 year	ARC definition of stent Thrombosis

Trial Locations

Locations (1)

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom