Non Valvular AF ,AFNCT04110197

Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients

An observational study of Non Valvular AF ,AF, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

1. To describe the patterns of care of newly diagnosed patients with NVAF vs VAF in the first-line, second-line and beyond second line setting, including, treatment plan, regimen, dosing, duration of treatment, and reason for interruption and termination along with treatment switching at any point of treatment… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Valvular AF ,AF
How many people: 84 participants
Where: 1 siteEgypt
Study dates: 1 Nov 2019to 1 Dec 2021
How long will I take part?: 6 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: This is a prospective observational study to be carried out in Assiut University Heart Hospital. The study is designed to capture real-world evidence (RWE) on patients' characteristics and the clinical management of patients with with NVAF vs VAF. All consecutive patients that are newly diagnosed with NVAF within the recruitment period (estimated to be 6 months) and 90 days before baseline visit and who meet the study inclusion/exclusion criteria will be invited to participate in the study. The study periods may be revised based on recruitment rate.

Who may be able to join

1. All male or female patients aged 18 years and older at the date of inclusion.
2. Patient newly diagnosed [within the recruitment period (estimated to be 6 months) and 90 days before the baseline visit] with atrial fibrillation (AF) and for whom treatment has started by the caring physician for the prevention of stroke/systemic embolism.
3. Signed informed consent.

Who cannot join

2. Severe psychiatric illness or other disease or circumstances that could compromise participation in the study. Patients will not be enrolled if major difficulties with follow-up will be anticipated, for example, patients with no valid residency permit or those planning to leave the country before the next scheduled follow-up.
3. Current participation in an interventional clinical trial at baseline. 4. AF with a generally reversible cause defined as non-cardiac surgery, post-cardiac surgery (AF within 3 months after surgery), hyperthyroidism, pulmonary embolism, pneumonia and acute myocardial infarction.
5. Mechanical heart valves or valve disease expected to require valve replacement.
6. A medical condition other than AF for which chronic use of VKA/NOAC is indicated.
7. Pregnant or breast-feeding women. Pregnancy to be ruled out according normal practice method of each site.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting

Assiut university
Asyut, 71511
hossam hassan, professor, 01223971327, hossam_hassan@hotmail.com
Recruiting

Other trials in Egypt

About this study

To describe the patterns of care of newly diagnosed patients with NVAF vs VAF in the first-line, second-line and beyond second line setting, including, treatment plan, regimen, dosing, duration of treatment, and reason for interruption and termination along with treatment switching at any point of treatment, regardless if the patients are considered of first line, second line or further within the treatments.
To describe the clinical outcomes (stroke/systemic embolism, bleeding complications, as well as cause-specific and all-cause mortality) with NVAF vs VAF.
To describe the values and distribution of International normalized ratio (INR) in patients who received VKAs and to assess the influence of Time in therapeutic range (TTR) and INR history on clinical outcomes (stroke/systemic embolism, bleeding complications) with NVAF vs VAF.
To evaluate AF-related healthcare resource utilization and direct costs associated with the management of AF patients with NVAF vs VAF. and To describe the baseline clinical and demographic characteristics as well as risk factors among patients newly diagnosed with NVAF versus VAF.

Conditions: Non Valvular AF ,AF

What is being measured

The primary outcome is the main question the study is designed to answer.

● Stroke: hemorrhagic or ischemic; ● Transient Ischemic Attack (TIA); ● Systemic embolism; ● Bleeding events (see definitions and categories below); ● Myocardial infarction; ● All-cause mortality.
- Acute clinically overt bleeding accompanied by one or more of the following:
- A decrease in hemoglobin (Hgb) of 2 g/dL or more over a 24-hour period;
- A transfusion of 2 or more units of packed red blood cells.
- Bleeding that occurs in at least one of the following critical sites:
- Intracranial;
- Intra-spinal;
- Intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed);
- Pericardial;
- Intra-articular;
- Intramuscular with compartment syndrome;
- Retroperitoneal.
- Bleeding that is fatal.
Measured: 6 monthes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20191 Dec 2021

First posted1 Oct 2019
Study start1 Nov 2019 (estimated)
Primary completion1 Dec 2020 (estimated)
Study completion1 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Valvular AF ,AFStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 84 participants (estimated)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04110197
Sponsor's protocol ID: non valvular AF
Status last verified: Sep 2019
First submitted: 27 Sep 2019
Last updated: 1 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: demographic base line , medical history clinical picture and complications treatment compliance follow up hospital admission and health resources

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet
Combined Pulsed-field Ablation (PFA)
Recruiting
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Intracranial Hemorrhages, Atrial Fibrillation (AF)

All Non Valvular AF ,AF trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients
ClinicalTrials.gov ID: NCT04110197
Acronym / sponsor ID: non valvular AF
Conditions: Non Valvular AF ,AF
Study type: Observational
Recruitment status: Unknown status
Enrolment: 84 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 1 Nov 2019 (estimated)
Primary completion: 1 Dec 2020 (estimated)
Study completion: 1 Dec 2021 (estimated)
First posted: 1 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To describe the patterns of care of newly diagnosed patients with NVAF vs VAF in the first-line, second-line and beyond second line setting, including, treatment plan, regimen, dosing, duration of treatment, and reason for interruption and termination along with treatment switching at any point of treatment, regardless if the patients are considered of first line, second line or further within the treatments.
To describe the clinical outcomes (stroke/systemic embolism, bleeding complications, as well as cause-specific and all-cause mortality) with NVAF vs VAF.
To describe the values and distribution of International normalized ratio (INR) in patients who received VKAs and to assess the influence of Time in therapeutic range (TTR) and INR history on clinical outcomes (stroke/systemic embolism, bleeding complications) with NVAF vs VAF.
To evaluate AF-related healthcare resource utilization and direct costs associated with the management of AF patients with NVAF vs VAF. and To describe the baseline clinical and demographic characteristics as well as risk factors among patients newly diagnosed with NVAF versus VAF.

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 6 Months

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: This is a prospective observational study to be carried out in Assiut University Heart Hospital. The study is designed to capture real-world evidence (RWE) on patients' characteristics and the clinical management of patients with with NVAF vs VAF. All consecutive patients that are newly diagnosed with NVAF within the recruitment period (estimated to be 6 months) and 90 days before baseline visit and who meet the study inclusion/exclusion criteria will be invited to participate in the study. The study periods may be revised based on recruitment rate.

Key inclusion criteria (3 listed)

1. All male or female patients aged 18 years and older at the date of inclusion.
2. Patient newly diagnosed [within the recruitment period (estimated to be 6 months) and 90 days before the baseline visit] with atrial fibrillation (AF) and for whom treatment has started by the caring physician for the prevention of stroke/systemic embolism.
3. Signed informed consent.

Key exclusion criteria (5 listed)

2. Severe psychiatric illness or other disease or circumstances that could compromise participation in the study. Patients will not be enrolled if major difficulties with follow-up will be anticipated, for example, patients with no valid residency permit or those planning to leave the country before the next scheduled follow-up.
3. Current participation in an interventional clinical trial at baseline. 4. AF with a generally reversible cause defined as non-cardiac surgery, post-cardiac surgery (AF within 3 months after surgery), hyperthyroidism, pulmonary embolism, pneumonia and acute myocardial infarction.
5. Mechanical heart valves or valve disease expected to require valve replacement.
6. A medical condition other than AF for which chronic use of VKA/NOAC is indicated.
7. Pregnant or breast-feeding women. Pregnancy to be ruled out according normal practice method of each site.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

● Stroke: hemorrhagic or ischemic; ● Transient Ischemic Attack (TIA); ● Systemic embolism; ● Bleeding events (see definitions and categories below); ● Myocardial infarction; ● All-cause mortality.
Time frame: 6 monthes
* Acute clinically overt bleeding accompanied by one or more of the following: * A decrease in hemoglobin (Hgb) of 2 g/dL or more over a 24-hour period; * A transfusion of 2 or more units of packed red blood cells. * Bleeding that occurs in at least one of the following critical sites: * Intracranial; * Intra-spinal; * Intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed); * Pericardial; * Intra-articular; * Intramuscular with compartment syndrome; * Retroperitoneal. * Bleeding that is fatal.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Individual participant dataSharing planned: Yes. demographic base line , medical history clinical picture and complications treatment compliance follow up hospital admission and health resources

Related trials for Non Valvular AF ,AF

Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet
Combined Pulsed-field Ablation (PFA)
Recruiting
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Intracranial Hemorrhages, Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Assiut university

Asyut, Egypt

01223971327

hossam_hassan@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non Valvular AF ,AF, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

● Stroke: hemorrhagic or ischemic; ● Transient Ischemic Attack (TIA); ● Systemic embolism; ● Bleeding events (see definitions and categories below); ● Myocardial infarction; ● All-cause mortality. (time frame: 6 monthes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.