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

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Conservative Arm
Invasive Arm
Sponsored by
Brighton and Sussex University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring Revascularisation, octogenarian,acute coronary syndromes

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Sussex County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Conservative Arm- Medical therapy

Invasive Arm-angiogram with PCI or CABG

Arm Description

Medical therapy

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
Major bleeding
BARC (Bleeding Academic Research Consortium) definition
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
Angina symptoms (3 months; 1yr)
CCS (Canadian Cardiovascular Society Classification of angina) grading of angina
Stent thrombosis
ARC definition of stent Thrombosis
All cause mortality
Cardiac and non cardiac mortality
Hospital readmission for ACS/STEMI
ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction)
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.

Full Information

First Posted
March 4, 2014
Last Updated
January 26, 2021
Sponsor
Brighton and Sussex University Hospitals NHS Trust
Collaborators
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT02086019
Brief Title
Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes
Acronym
RINCAL
Official Title
A Prospective Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (undefined)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brighton and Sussex University Hospitals NHS Trust
Collaborators
Medtronic Vascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
Revascularisation, octogenarian,acute coronary syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Arm- Medical therapy
Arm Type
Other
Arm Description
Medical therapy
Arm Title
Invasive Arm-angiogram with PCI or CABG
Arm Type
Other
Arm Description
same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate
Intervention Type
Drug
Intervention Name(s)
Conservative Arm
Other Intervention Name(s)
low molecular weight heparin,, aspirin,, clopidogrel,, beta blocker (Bisoprolol or equivalent), ACE inhibitor (Ramipril or equivalent)
Intervention Description
crossover to angiogram only if predefined criteria met
Intervention Type
Procedure
Intervention Name(s)
Invasive Arm
Intervention Description
angiogram with PCI or CABG revascularisation if appropriate
Primary Outcome Measure Information:
Title
Death
Description
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.
Time Frame
1 year
Title
non-fatal myocardial infarction
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Unplanned revascularisation
Description
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.
Time Frame
1 years
Title
Permanent Stroke
Description
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
Time Frame
1 year
Title
Major bleeding
Description
BARC (Bleeding Academic Research Consortium) definition
Time Frame
1 year
Title
Deterioration of renal function during hospital admission
Description
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
Time Frame
During index admission
Title
Angina symptoms (3 months; 1yr)
Description
CCS (Canadian Cardiovascular Society Classification of angina) grading of angina
Time Frame
3 months and 1 year
Title
Stent thrombosis
Description
ARC definition of stent Thrombosis
Time Frame
1 year
Title
All cause mortality
Description
Cardiac and non cardiac mortality
Time Frame
2,3 and 4 year
Title
Hospital readmission for ACS/STEMI
Description
ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction)
Time Frame
At 3, 6 and 12 months and at 2,3 and 4 years
Title
In-hospital major complications
Description
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.
Time Frame
At 3, 6 and 12 months and at 2,3 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

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Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

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