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

NCT03012906 | Unknown

• 1 other identifier: 2016-16
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (3)

• Number of deaths

  2 years

• Number of myocardial infarctions

  2 years

• Number of strokes

  2 years

Secondary Outcomes (1)

• The prevalence of bleeding events

  2 years

Interventions

the prevalence of ischemic events OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing percutaneous coronary intervention (PCI)

You may qualify if:

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

You may not qualify if:

• pregnancy or lactation
• age \<18 or not able to give an informed consent
• no informed consent
• no health insurance
• prisoners
• contra indication to antiplatelet therapy
• intra cardiac thrombus
• active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)
• severe kidney failure (eGFR \< 30 mL/min/1.73 m²)
• severe hepatic failure (Child-Pugh class B or C)
• contra indication to OAC or VKA
• hypertrophic myocardiopathy
• valvular prosthesis
• history of peptic ulcer

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

Study Officials

• Catherine GEINDRE

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• Laurent bonello

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent bonello

CONTACT

laurent.bonello@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)