Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

Acute Coronary Syndromes Clinical Trial

— RINCAL  

Official title:

A Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086019
• Other study ID #: BN-AdB-RINCAL-2013
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: December 12, 2019

Study information

• Verified date: January 2021
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 12, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

Intervention

Drug:
• Conservative Arm
crossover to angiogram only if predefined criteria met

Procedure:
• Invasive Arm
angiogram with PCI or CABG revascularisation if appropriate

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton

Sponsors (2)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust	Medtronic Vascular

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Major bleeding	BARC (Bleeding Academic Research Consortium) definition	1 year
Secondary	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
Secondary	Angina symptoms (3 months; 1yr)	CCS (Canadian Cardiovascular Society Classification of angina) grading of angina	3 months and 1 year
Secondary	Stent thrombosis	ARC definition of stent Thrombosis	1 year
Secondary	All cause mortality	Cardiac and non cardiac mortality	2,3 and 4 year
Secondary	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
Secondary	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