Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT03012906
First received: January 5, 2017
Last updated: January 5, 2017
Last verified: January 2017
  Purpose

Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).

Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.

Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.

These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.

The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .


Condition Intervention
Percutaneous Coronary Intervention
Other: the prevalence of ischemic events

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Number of deaths [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of myocardial infarctions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of strokes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The prevalence of bleeding events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: January 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing percutaneous coronary intervention (PCI)
Criteria

Inclusion Criteria:

  1. age over 18 years old
  2. signed informed consent
  3. requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
  4. FA requiring chronic anticoagulation (CHA2DS2-VASc >1, except women with a score =1).

Exclusion Criteria:

  1. pregnancy or lactation
  2. age <18 or not able to give an informed consent
  3. no informed consent
  4. no health insurance
  5. prisoners
  6. contra indication to antiplatelet therapy
  7. intra cardiac thrombus
  8. active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)
  9. severe kidney failure (eGFR < 30 mL/min/1.73 m²)
  10. severe hepatic failure (Child-Pugh class B or C)
  11. contra indication to OAC or VKA
  12. hypertrophic myocardiopathy
  13. valvular prosthesis
  14. history of peptic ulcer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03012906

Contacts
Contact: Laurent bonello laurent.bonello@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Catherine GEINDRE Assistance Publique Hopitaux De Marseille
Principal Investigator: Laurent bonello Assistance Publique Hopitaux De Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03012906     History of Changes
Other Study ID Numbers: 2016-16 
Study First Received: January 5, 2017
Last Updated: January 5, 2017
Health Authority: France: Commission nationale de l'informatique et des libertés
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Platelet Aggregation Inhibitors
Anticoagulants

ClinicalTrials.gov processed this record on January 17, 2017