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Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI (Matador-PCI)

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ClinicalTrials.gov Identifier: NCT03656523
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation

Brief Summary:

ACS are a potent risk factor for AF, with new onset AF occurring in up to 1 in every 5 patients hospitalized with an ACS.

Despite its relatively frequent occurrence and the many etiologic factors involved in its pathogenetic condition, the frequency and prognostic significance of AF complicating ACS remain unclear


Condition or disease Intervention/treatment
Acute Coronary Syndrome Atrial Fibrillation Other: Acute coronary syndrome and PCI and AF

Detailed Description:

There are limited data available, particularly from a representative population-based perspective describing recent pharmacological and non-pharmacological management and clinical event rates associated with AF complicating ACS in the era of novel treatment strategies (in both AF and ACS) and high coronary reperfusion rates.

This registry will assess the current in-hospital management and clinical events at 6 months of consecutive patients admitted in Italian cardiology intensive care units (CCUs) for an ACS treated invasively with PCI and stent implantation who present AF at admission or during hospital stay, before or after stent implantation .

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Study Type : Observational [Patient Registry]
Actual Enrollment : 598 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI
Actual Study Start Date : July 25, 2018
Actual Primary Completion Date : August 17, 2020
Actual Study Completion Date : August 17, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute Coronary Syndrome
Patients with Aute coronary syndrome trated with Percutaneous Coronary Intervention plus Stent implantation and Atrial Fibrillation
Other: Acute coronary syndrome and PCI and AF
Patient with ACS and ACS treated with PCI




Primary Outcome Measures :
  1. Clinical epidemiology [ Time Frame: Enrollement ]
    Demographics

  2. Management [ Time Frame: 6 months ]
    Pharmacological treatment

  3. Antithrombotic strategy [ Time Frame: 6 months ]
    Intravenous or oral antiplatelet and anticoagulation therapies and their combination

  4. Clinical epidemiology [ Time Frame: Enrollement ]
    Clinical history

  5. Clinical epidemiology [ Time Frame: Enrollement ]
    Type of AF

  6. Clinical epidemiology [ Time Frame: Enrollement ]
    Type of ACS

  7. Management [ Time Frame: 6 months ]
    Time of PCI

  8. Number of procedure performed on enrolled patients [ Time Frame: 6 months ]
    In-hospital management


Secondary Outcome Measures :
  1. Pharmacological therapies [ Time Frame: 6 months ]
    Use and persistence of therapies prescribed at discharge

  2. Clinical outcomes [ Time Frame: 6 months ]
    All cause deaths, major bleedings, non fatal stroke, systemic embolism, transiet ischemic attach, MI recurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with ACS trated with PCI with stent implantation developing or having Atrial Fibrillation.
Criteria

Inclusion Criteria:

  • All consecutive ACS patients treated with PCI with stent implantation who present AF at admission or during hospital stay, before or after stent implantation.

Exclusion Criteria:

  • Patients admitted with a diagnosis of ACS at the time of enrolment but not confirmed during hospitalization
  • ACS treated medically or with PCI but without stent implantation
  • Patients not giving informed consent

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): NCT03656523


Locations
Show Show 76 study locations
Sponsors and Collaborators
Heart Care Foundation
Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT03656523    
Other Study ID Numbers: K20
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart Care Foundation:
Acute Coronary Syndrome
Atrial Fibrillation
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Atrial Fibrillation
Acute Coronary Syndrome
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases