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

Percutaneous Coronary Intervention Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03012906
• Other study ID #: 2016-16
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2017
• Last updated: January 5, 2017
• Start date: January 2017
• Est. completion date: July 2019

Study information

• Verified date: January 2017
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Laurent bonello
• Email: laurent.bonello[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Percutaneous Coronary Intervention

Intervention

Other:
• the prevalence of ischemic events

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of deaths		2 years	No
Primary	Number of myocardial infarctions		2 years	No
Primary	Number of strokes		2 years	No
Secondary	The prevalence of bleeding events		2 years	Yes