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Trial record 2 of 2 for:    PIONEER AF-PCI

CHAOS Registry Study (CHAOS)

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ClinicalTrials.gov Identifier: NCT03558295
Recruitment Status : Unknown
Verified June 2018 by Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino.
Recruitment status was:  Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary:

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.


Condition or disease Intervention/treatment
Ischem Heart Disease Primary Coronay Intervention Oral Anticoagulants Atrial Fibrillation Drug: Oral Anticoagulant

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CHoosing Triple or Double therApy in the Era of nOac for patientS Undergoing PCI: the CHAOS a Multicenter Study.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Oral Anticoagulant
    warfarin, dabigatran, rivaroxaban, edoxaban


Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  2. Target vessel revascularization (TVR) and non TVR and the number of the revascularization. [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  3. Death [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  4. Myocardial infarction [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  5. Stent thrombosis [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  6. Recurrent revascularization [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  7. Stroke [ Time Frame: after 12 months ]
    Expressed as a rate of events.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558295


Contacts
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Contact: Fabrizio D'Ascenzo, MD +390116335570 fabrizio.dascenzo@gmail.com

Locations
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Italy
Città della Salute e della Scienza di Torino Recruiting
Torino, Piemonte, Italy, 10100
Contact: Fabrizio D'Ascenzo, MD    +390116335570    fabrizio.dascenzo@gmail.com   
Principal Investigator: Fabrizio D'Ascenzo, MD         
Sub-Investigator: Mattia Peyracchia, MD         
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Additional Information:

Publications of Results:

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Responsible Party: Fabrizio D'Ascenzo, Principal Investigator, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT03558295    
Other Study ID Numbers: CHAOS
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino:
Percutaneous coronary intervention (PCI), oral anticoagulants, atrial fibrillation, DOAC.
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Anticoagulants