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

January 26, 2021 updated by: Adam de Belder, Brighton and Sussex University Hospitals NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 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.
1 year
non-fatal myocardial infarction
Time Frame: 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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unplanned revascularisation
Time Frame: 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.
1 years
Permanent Stroke
Time Frame: 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
1 year
Major bleeding
Time Frame: 1 year
BARC (Bleeding Academic Research Consortium) definition
1 year
Deterioration of renal function during hospital admission
Time Frame: 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
During index admission
Angina symptoms (3 months; 1yr)
Time Frame: 3 months and 1 year
CCS (Canadian Cardiovascular Society Classification of angina) grading of angina
3 months and 1 year
Stent thrombosis
Time Frame: 1 year
ARC definition of stent Thrombosis
1 year
All cause mortality
Time Frame: 2,3 and 4 year
Cardiac and non cardiac mortality
2,3 and 4 year
Hospital readmission for ACS/STEMI
Time Frame: 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)
At 3, 6 and 12 months and at 2,3 and 4 years
In-hospital major complications
Time Frame: 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.
At 3, 6 and 12 months and at 2,3 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brighton and Sussex University Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic Vascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BN-AdB-RINCAL-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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