Clinical trial NCT03942913: Prospective Real-world Registry Describing Treatment Regimens
Official title: Real-world Prospective Registry to Describe the Current Treatment Patterns With Oral Anticoagulant and Antiplatelet Agents Association in Patients With Atrial Fibrillation and Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subject Under Anticoagulant
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The recruiting will be performed in emergency and cardiologic units by using a consecutive screening and enrollment strategy. Information obtained as part of routine care will be reviewed to determine eligibility for enrollment including 12 lead electrocardiograms and medical exam, cardiac biomarker and all means considered necessary for diagnosis of intermediate-risk and high-risk ACS. For all patients undergoing an invasive strategy and requiring chronic anticoagulant therapy for AF, the site will carefully review the inclusion and exclusion criteria described in the protocol to confirm the subject's eligibility.

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.

Eligibility criteria: 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

Primary outcomes:
measure: frequency of patients treated after PCI with each drug class.
timeFrame: 1 year
Secondary outcomes:
measure: The type, the daily dosage and the duration of each drug class
timeFrame: 18 MONTHS
measure: The type, the daily dosage and the duration of each drug combination
timeFrame: 18 MONTHS
measure: tthe type of bleeding events according TIMI classification1 for each drug
timeFrame: 18 MONTHS
measure: The major adverse cardiovascular events (MACE)
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References: