Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03977363
Status:
TERMINATED
Last Update Posted:
2023-05-17
First Post:
2019-06-05
Brief Title:
The Portuguese Survey on Anticoagulated Patients Register START-Portugal-Register
Sponsor:
CHAD
Organization:
Association for Innovation and Biomedical Research on Light and Image
Study Overview
Official Title:
The Portuguese Survey on Anticoagulated Patients Register START-Portugal-Register
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted Prematurely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START-Portugal
Brief Summary:
Anticoagulants are used to prevent thrombotic events in patients with predisposing factors However the use of such therapies is associated with bleeding complications which can be a serious safety issue Thus it is important to evaluate the safety and effectiveness of such therapies based on data collected in clinical practice in order to generate relevant scientific data that could be used to support clinical and regulatory decisions
This is an open prospective multicenter observational cohort study that aims to prospectively record the clinical history of adult patients receiving anticoagulant treatment irrespectively of the prescribed drug and the indication for its use
This is an open prospective multicenter observational cohort study that aims to prospectively record the clinical history of adult patients receiving anticoagulant treatment irrespectively of the prescribed drug and the indication for its use
Detailed Description:
The Portuguese Survey on anTicoagulated pAtients RegisTer START-Portugal-Register is an open prospective multicenter observational cohort study that intends to record the clinical history of adult patients receiving anticoagulant therapies providing real-world data on the safety and effectiveness of such therapies as well as to serve as the starting point of collaborative clinical studies enabling their planning and execution
The START-Portugal-Register is designed solely for observational purposes it is not intended to have any influence on the treatment of included patients
Objectives
To prospectively record the clinical history of adult patients receiving anticoagulant treatment irrespectively of the prescribed drug and the indication for its use
To enhance the understanding of risks and benefits associated with the use of anticoagulant drugs in routine clinical practice
To prospectively record decisions and reasons guiding physicians decisions in order to manage anticoagulant treatment options in routine clinical practice
To improve knowledge on the epidemiologic diagnostic and clinical features of thrombotic diseases
To generate real-world evidence on the safety and effectiveness of anticoagulant drugs therefore contributing to support informed clinical decisions
The START-Portugal-Register is open to the participation of clinical centers and individual physicians that are involved in the management of patients undergoing anticoagulant treatment
Patients who sign the informed consent and fulfil the inclusionexclusion criteria will be enrolled in the study and considered for data analysis
Follow-up mandatory for at least 12 months Nevertheless a long-term follow-up is recommended for patients who receive an indefinite anticoagulation treatment The START-Portugal-Register sets itself an indefinite time limit
A descriptive analysis will be conducted for all study variables A propensity score model will be applied to compare the safety and efficacy of the different anticoagulant treatments
The START-Portugal-Register is designed solely for observational purposes it is not intended to have any influence on the treatment of included patients
Objectives
To prospectively record the clinical history of adult patients receiving anticoagulant treatment irrespectively of the prescribed drug and the indication for its use
To enhance the understanding of risks and benefits associated with the use of anticoagulant drugs in routine clinical practice
To prospectively record decisions and reasons guiding physicians decisions in order to manage anticoagulant treatment options in routine clinical practice
To improve knowledge on the epidemiologic diagnostic and clinical features of thrombotic diseases
To generate real-world evidence on the safety and effectiveness of anticoagulant drugs therefore contributing to support informed clinical decisions
The START-Portugal-Register is open to the participation of clinical centers and individual physicians that are involved in the management of patients undergoing anticoagulant treatment
Patients who sign the informed consent and fulfil the inclusionexclusion criteria will be enrolled in the study and considered for data analysis
Follow-up mandatory for at least 12 months Nevertheless a long-term follow-up is recommended for patients who receive an indefinite anticoagulation treatment The START-Portugal-Register sets itself an indefinite time limit
A descriptive analysis will be conducted for all study variables A propensity score model will be applied to compare the safety and efficacy of the different anticoagulant treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None