CHAOS Registry Study (CHAOS)

June 14, 2018 updated by: Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

CHoosing Triple or Double therApy in the Era of nOac for patientS Undergoing PCI: the CHAOS a Multicenter Study.

INTRODUCTION: About 6-8% of patients undergoing PCI have an indication for long-term oral anticoagulants (OACs) due to various conditions such as atrial fibrillation (AF), mechanical heart valves, or venous thromboembolism. The addition of single or double antiplatelet therapy to OACs therapy results in an increase in bleeding complications (1-4). The standard of care of management in this patients, indicated by 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease (5), recommends the use of a triple therapy (Aspirin, clopidogrel and OAC) for 1-6 months (depending on the ischemic and hemorrhagic risk), then continue with double therapy only up to twelve month (Aspirin or clopidogrel and OAC) and after twelve months continue with the OAC only; the use of prasugrel or ticagrelor as part of triple therapy should be avoided (6). Only RELY study enrolled a small number of patients, less than one thousand, treated with dabigatran plus DAPT. Moreover, In the recent RCTs (WOEST(7), PIONEER AF-PCI study(8) and REDUAL-PCI(9)) only the double therapy (Aspirin or Clopidogrel/ticagrelor and DOAC) against triple therapy with warfarin was tested; and furthermore patients enrolled in RCTs represent only a small and not always representative sample of people treated in everyday clinical practice, who report a large burden of comorbidities and an older age. Randomized head to head comparison of warfarin and DOACs life-long (over 12 months from the PCI) have not been performed yet with clinical events as end points.

AIMS: Aim of the present study is to describe the contemporary management of patients who underwent a PCI and have an indication to OAC for AF evaluating the different types of combination therapies used (triple therapy with warfarin or with DOAC, single anti-platelet therapy plus warfarin or DOAC) and their management in the first year after a PCI in a "real-life" setting. Secondary we would also evaluate the safety (in term of bleedings) and the efficacy (in term of ischemic and cardioembolic events) of the use of the different combination of single or double antiplatelet with OACs, in patients with coronary artery disease.

MATERIALS AND METHODS: This is a retrospective, multicenter study including patients presenting with coronary artery disease (acute or stable setting) undergoing to PCI, in single or double antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel, aspirin and clopidogrel, aspirin and ticagrelor, aspirin and prasugrel) with an indication to anticoagulant therapy (warfarin, dabigatran, rivaroxaban, edoxaban). The different groups will be compared with a propensity score analysis with matching.

Primary (efficacy) end-points:

  • A composite end points including death, myocardial infarction, stent thrombosis, revascularization stroke (MACE).
  • A composite end points including death, myocardial infarction, stent thrombosis, revascularization, stroke and BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (7,8): all events mutually exclusive (NACE).

Secondary end-points: Individual components of NACE; Cardiac death; Stroke; Target vessel revascularization (TVR) and non TVR and the number of the revascularization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

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

  • Italy
    • Piemonte
      • Torino, Piemonte, Italy, 10100
        • Recruiting
        • Città della Salute e della Scienza di Torino

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

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease (acute or stable setting) in single or double antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel, aspirin and clopidogrel, aspirin and ticagrelor, aspirin and prasugrel) associated with oral anticoagulant (warfarin, dabigatran, rivaroxaban, edoxaban)

Description

Inclusion Criteria:

  • Patients with final diagnosis of CAD (stable CAD or ACS) treated with oral anticoagulants and who undwerwent a coronary artery intervention
  • Age ≥ 18 years
  • Obtained informed consent

Exclusion Criteria:

  • Oral anticoagulation indication other than atrial fibrillation
  • Patients who underwent revascularization with thrombolysis or with BPAC
  • Patients in active treatment with anti-cancer therapy
  • Patients with a non obstructive coronary artery disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary (efficacy and safety) end-points:Net Adverse Clinical Event - NACE
Time Frame: 12 months

Primary (efficacy and safety) end-points:

- Net Adverse Clinical Event - NACE at 12 months of follow up (a composite end points including death, myocardial infarction, stent thrombosis, revascularization, stroke and BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (8,9): all events mutually exclusive); expressed as a rate of events.
12 months
Primary (efficacy and safety) end-points:Major Adverse Cardiac Event - MACE at 12 months
Time Frame: 12 months

Primary (efficacy and safety) end-points:

- Major Adverse Cardiac Event - MACE at 12 months of follow up (a composite end points including death, myocardial infarction (excluding periprocedural myocardial infarction), stent thrombosis, revascularization, stroke); expressed as a rate of events.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Target vessel revascularization (TVR) and non TVR and the number of the revascularization.
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Death
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Myocardial infarction
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Stent thrombosis
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Recurrent revascularization
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Stroke
Time Frame: after 12 months
Expressed as a rate of events.
after 12 months
Bleeding BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (8,9): all events mutually exclusive); expressed as a rate of events.
Time Frame: after 12 months
According with BARC [Bleedings according to the Bleeding Academic Research Consortium] 2,3,5 (8,9): all events mutually exclusive); expressed as a rate of events.
after 12 months

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2018

Primary Completion (Anticipated)

October 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHAOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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