Prospective Real-world Registry Describing Treatment Regimens

• Conditions: Subject Under Anticoagulant
• Interventions: Other: an observational study

• Registration Number: NCT03942913
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

This study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.

Detailed Description

Coordinator of project has strong expertise in cardiovascular research and especially in ACS, PCI and antiplatelet therapy. The group led by pr Bonello has published several articles (appendix 3) including the VASP studies which have been presented at major cardiologic congresses (late breaking trials ACC 2007, AHA 2008, TCT 2011, EuroPCR 2010) including physicians and biologists. The group is composed of international experts in this research field (Pr Bonello, Pr Cuisset, Dr Barragan, Pr Lemesle). Additionally, coordinator center has a strong expertise in clinical research and a methodological support will be provided by the Clinical Research Platform of the AP-HM (responsible: Prof. Pascal Auquier, medical referent: Dr Karine Baumstarck).

The project brings together investigators that have been previously involved in many clinical studies in the field of ACS and PCI. In particular they have joined forces on multicenter trials leaded by the cardiology department of the Hôpital Universitaire Nord de Marseille (the VASP studies, the Early clinical trial) and they have regular meetings to share scientific data and research program design and advancement. There is a good capacity and ability of recruitment by the partner centers. The procedures to perform in this project are very simple and the disease is frequent. These are good criteria for the feasibility.

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-10-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-16
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 573

Inclusion Criteria

The eligible subjects must meet all of the following criteria:

• Man or woman 18 years old or over
• Subject requiring percutaneous coronary intervention according to physician's and with AF requiring chronic anticoagulation by dual therapy or triple therapy;
• Subject with pulmonary embolism risk score > 1 for men and ≥ 1 for women in CHA2DS2-VASc classification
• Subject having declare its non-opposition to study participation

Exclusion Criteria

• Child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile)
• Lactation
• No health insurance
• Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dual therapy	an observational study	including 1 antiplatelet treatment aspirin or clopidogrel associated with 1 anticoagulant treatment VKA or NOAC.
triple therapy	an observational study	including 2 antiplatelet treatments (aspirin and clopidogrel) associated with 1 anticoagulant treatment VKA or NOAC. In VKA class, 2 different drugs are commonly prescribed: warfarin and fluidinione. In NOAC class, 3 different drugs are commonly prescribed: rivaroxaban, apixaban, dabigatran.

Primary Outcome Measures

Name	Time	Method
frequency of patients treated after PCI with each drug class.	1 year

Secondary Outcome Measures

Name	Time	Method
tthe type of bleeding events according TIMI classification1 for each drug	18 MONTHS
The major adverse cardiovascular events (MACE)	18 months
The type, the daily dosage and the duration of each drug class	18 MONTHS
The type, the daily dosage and the duration of each drug combination	18 MONTHS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France