StrokeNCT04808934
NOAC Portuguese Real World Study
An observational study of Stroke and Systemic Embolism, run by Pfizer.
Trial summary
To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Systemic Embolism, Major Bleeding
- What is being tested?
- Apixaban, dabigatran and rivaroxaban
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients will be selected from the CCF database based on an apixaban, dabigatran, rivaroxaban or VKAs filled prescription between June 16, 2014 and December 31, 2018.
Who may be able to join
- Age ≥18 years on the index date.
- At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.
Who cannot join
- Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
- Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
- The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
- Hospital claims lacking a diagnosis code indicative of AF during the study period;
- Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
- Hospital claim indicating a diagnosis or procedure code indicative of valvular heart disease, venous thromboembolism, cardiac surgery, pericarditis, hyperthyroidism and thyrotoxicity during the baseline period;
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- Hospital claim indicating a diagnosis or procedure code indicative of hip and knee replacement surgery during the 6 weeks prior to the index date. Patients with past use of OAC will be excluded. Therefore, patients meeting any of the following criteria will be excluded:
- Had any OAC (apixaban, dabigatran, edoxaban, rivaroxaban, VKAs) dispensed during the 12-month baseline period;
- Had >1 OAC dispensed on the index date.
About this study
Official title: Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data
To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists
- Conditions
- Stroke, Systemic Embolism, Major Bleeding
- Being tested
- Apixaban, dabigatran, rivaroxaban, VKAs
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Adults receiving apixaban
dabigatranDrug
Adults receiving dabigatran
rivaroxabanDrug
Adults receiving rivaroxaban
VKAsDrug
Adults receiving VKA
| Study group | Role | What they receive |
|---|---|---|
| Non-Valvular Atrial Fibrillation (NVAF) Adults | Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018. Receives: Drug: Apixaban; Drug: dabigatran; Drug: rivaroxaban; Drug: VKAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke/systemic embolism event
To compare the risk of stroke (either ischemic or hemorrhagic) or SE among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: between 2014 and 2018
major bleeding event
To compare the risk of major bleeding (gastrointestinal [GI], intracranial [IC] and other) among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versusVKAs.
Measured: between 2014 and 2018
Secondary outcomes (6)
ischemic stroke event
To compare the risk of ischemic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: between 2014 and 2018
hemorrhagic stroke event
To compare the risk of hemorrhagic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: between 2014 and 2018
systemic embolism event
To compare the risk of systemic embolism among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: 2014-2018
major GI bleeding event
To compare the risk of major GI bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: 2014-2018
major IC bleeding event
To compare the risk of major IC bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: 2014-2018
other major bleeding event
To compare the risk of other major bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
Measured: 2014-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808934
- Sponsor's protocol ID
- X9001275
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data
- ClinicalTrials.gov ID
- NCT04808934
- Acronym / sponsor ID
- X9001275
- Conditions
- Stroke, Systemic Embolism, Major Bleeding
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 22 Mar 2021 (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 determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Valvular Atrial Fibrillation (NVAF) Adults | – | Drug: Apixaban, Drug: dabigatran, Drug: rivaroxaban, Drug: VKAsAdult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients will be selected from the CCF database based on an apixaban, dabigatran, rivaroxaban or VKAs filled prescription between June 16, 2014 and December 31, 2018.
Key inclusion criteria (2 listed)
- Age ≥18 years on the index date.
- At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.
Key exclusion criteria (9 listed)
- Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
- Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
- The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
- Hospital claims lacking a diagnosis code indicative of AF during the study period;
- Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAdults receiving apixaban | Drug | Non-Valvular Atrial Fibrillation (NVAF) Adults |
| dabigatranAdults receiving dabigatran | Drug | Non-Valvular Atrial Fibrillation (NVAF) Adults |
| rivaroxabanAdults receiving rivaroxaban | Drug | Non-Valvular Atrial Fibrillation (NVAF) Adults |
| VKAsAdults receiving VKA | Drug | Non-Valvular Atrial Fibrillation (NVAF) Adults |
Primary outcome
stroke/systemic embolism event
Time frame: between 2014 and 2018
To compare the risk of stroke (either ischemic or hemorrhagic) or SE among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major bleeding event
Time frame: between 2014 and 2018
To compare the risk of major bleeding (gastrointestinal [GI], intracranial [IC] and other) among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versusVKAs.
6 secondary outcomes
ischemic stroke event
Time frame: between 2014 and 2018
hemorrhagic stroke event
Time frame: between 2014 and 2018
systemic embolism event
Time frame: 2014-2018
major GI bleeding event
Time frame: 2014-2018
major IC bleeding event
Time frame: 2014-2018
other major bleeding event
Time frame: 2014-2018
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Systemic Embolism, run by Pfizer.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke/systemic embolism event (time frame: between 2014 and 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2023.