Prospective Real-world Registry Describing Treatment Regimens

NCT ID: NCT03942913

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

573 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-10

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subject Under Anticoagulant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dual therapy

including 1 antiplatelet treatment aspirin or clopidogrel associated with 1 anticoagulant treatment VKA or NOAC.

an observational study

Intervention Type OTHER

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

triple therapy

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.

an observational study

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

an observational study

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pr Laurent BONELLO

Role: CONTACT

+33(0)4 91 96 86 83

Alexandra Giuliani

Role: CONTACT

04 91 38 28 70

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

bonello laurent

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A00325-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.