Atrial FibrillationPAUSE2rctPNCT04192552
Perioperative Anticoagulant Use for Surgery Evaluation Study Part 2 Pilot
A study testing PAUSE Perioperative DOAC Management and ASRA Perioperative DOAC Management in people with Atrial Fibrillation, run by McMaster University at 3 sites in Canada.
Trial summary
The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PAUSE Perioperative DOAC Management and ASRA Perioperative DOAC Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 3 sitesCanada
- Study dates
- 9 Jan 2020to Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- Adult (age ≥18 years) with AF/flutter who is receiving a DOAC: apixaban 2.5 mg or 5 mg BID; dabigatran 110 mg or 150 mg BID; or rivaroxaban 15 mg or 20 mg QD.
- Undergoing an elective surgery/procedure associated with a high-bleed-risk or any surgery/procedure requiring neuraxial anesthesia (includes regional blocks)
- Patient and their clinician are willing to adhere to DOAC interruption/continuation protocols.
- Patient to resume DOAC after surgery/procedure (i.e., no intent to discontinue DOAC).
Who cannot join
- Creatinine clearance (CrCl) <30 mL/min (dabigatran, rivaroxaban) and <25 mL/min (apixaban) based on the Cockroft-Gault equation, which is recommended for DOAC dosing.
- Patient taking a DOAC that is infrequently used (i.e., edoxaban, <5% Canadian DOAC market share in 2018) or is not available for clinical use in Canada or Europe (i.e., betrixaban).
- Patient taking a DOAC for a non-AF clinical indication (excluded to maintain study population homogeneity).
- Cognitive impairment or psychiatric illness that precludes collection of follow-up data.
- Inability or unwillingness to provide informed consent.
- Previous participation in PAUSE-2.
Trial locations and contacts
3 sites in 1 country.
Joanne Duncan, MSc contact
Canada3 sites, 3 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
Michelle Zondag, 905-527-4322 ext. 43571, zondag@hhsc.ca
Sam Schulman, MD
- Not yet recruiting
Juravinski Hospital
Hamilton, Ontario
Carolyn Webb, 905-521-2100 ext. 43784, webbcar@hhsc.ca
Peter Gross, MD
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Terri Schnurr, 905-522-1155 ext. 33151, schnurt@mcmaster.ca
James Douketis, MD
About this study
Official title: Perioperative Anticoagulant (Dabigatran, Rivaroxaban, or Apixaban) Use for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF) Part 2 Randomized Control Trial Pilot
The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC) and require an elective surgery/procedure. PAUSE did not address safe management of patients having a high-bleed-risk surgery/neuraxial anesthesia in whom there is concern about bleeding, especially neuraxial-related epidural hematomas that can lead to paralysis; such patients are often managed by the approach recommended by the American Society of Regional Anesthesia (ASRA). In PAUSE-2, investigators will test the hypothesis: (i) for patients having a high-bleed-risk surgery/neuraxial anesthesia, the simpler "PAUSE management" is as safe (non-inferior) to the more complex "ASRA management". PAUSE-2 will establish a standard for perioperative DOAC management in patients having high-bleed-risk surgery or neuraxial anesthesia.
To start, this will be a pilot study of a larger PAUSE-2-RCT. The investigators will be conducting this pilot study to assess the feasibility of the study at this smaller scale.
Read the detailed description
The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018 and presented at the American Society of Hematology Conference on December 4, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC) (apixaban, dabigatran or rivaroxaban) and require an elective surgery/procedure. Standardized, DOAC-specific perioperative management is needed to: (i) minimize patient harm related to serious perioperative adverse events, comprising arterial thromboembolism (A-TE) and major bleeding (MB); and (ii) allow consistent, cost-efficient management that avoids cancelled surgeries/procedures and the need to reverse DOACs. PAUSE did not address safe management of patients having a high-bleed-risk surgery/neuraxial anesthesia in whom there is concern about bleeding, especially neuraxial-related epidural hematomas that can lead to paralysis; such patients are often managed by the approach recommended by the American Society of Regional Anesthesia (ASRA).
In PAUSE-2, the primary question is: (i) In patients having a high-bleed-risk surgery/neuraxial anesthesia, is the simple, shorter-DOAC-interruption PAUSE management as safe as the more complex, longer-interruption ASRA approach? Hypothesis: PAUSE management is non-inferior to ASRA management with expected perioperative risks in both groups of 2.5% for MB (2% non-inferiority margin) and 0.5% for A-TE (1% non-inferiority margin).
In PAUSE-2, the secondary question is: (i) are the PAUSE and ASRA management approaches associated with similar proportions of patients with minimal-to-no residual DOAC levels at surgery, and similar adherence to the DOAC interruption/resumption protocols? Exploratory postulate: PAUSE and ASRA approaches will have similar proportion of patients (±5%) with DOAC levels (<30, 30-49.9, and ≥50 ng/mL), and protocol adherence to perioperative DOACs interrupted and resumed.
Approximately 201 patients will be recruited for the PAUSE-2 Study pilot. This is 10% of the proposed main study (2,010 participants).
In all patients, a 5 mL blood sample will be taken just before surgery (but will be not available for clinical use and cannot be used for genetic testing). Plasma will be frozen and stored at each clinical site before shipment to the core laboratory at McMaster University for storage and standardized DOAC level measurement.
A focused patient enrolled before the procedure and followed up every week up to completion of their participation at 4 weeks (±5 days). Patients will be enrolled over a 1 year period.
To start, this will be a pilot study of a larger PAUSE-2-RCT. Conducting this pilot study will help assess the feasibility and methodology of the study at this smaller scale. It is important to evaluate the feasibility of recruitment, randomization and retention. As well, investigators need to assess the methodology and implementation of the randomized trial.
Note that the outcome for the pilot study is not to evaluate the safety of the perioperative procedure, but to examine the approach to be used in the intended larger study. The outcomes for the larger study will still be collected.
- Conditions
- Atrial Fibrillation
- Being tested
- PAUSE Perioperative DOAC Management, ASRA Perioperative DOAC Management
- Keywords
- anticoagulant, atrial fibrillation, surgery, oral anticoagulant, high risk, blood thinner, DOAC, interruption, discontinue, elective, perioperative
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAUSE Perioperative DOAC ManagementOther
Apixaban \& Rivaroxaban: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure.
Dabigatran (see below):
CrCl ≥50: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure.
CrCl <50: Hold DOAC for 4 days before procedure. Re-start DOAC 2+ days post-procedure.
ASRA Perioperative DOAC ManagementOther
Apixaban \& Rivaroxaban: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure.
Dabigatran (see below):
CrCl >80: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure.
CrCl 50-80: Hold DOAC for 4 days before procedure. Re-start DOAC 1+ days post-procedure.
CrCl 30-49: Hold DOAC for 5 days before procedure. Re-start DOAC 1+ days post-procedure.
*Low-dose heparin bridging can be used if at high A-TE risk
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Active comparator | Patients currently taking apixaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia. Receives: Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management |
| Dabigatran | Active comparator | Patients currently taking dabigatran that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia. Receives: Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management |
| Rivaroxaban | Active comparator | Patients currently taking rivaroxaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia. Receives: Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who had a major bleed
≥1 of the criteria below:
- bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular
- non-surgical bleeding causing a drop in hemoglobin ≥20 g/L (1.24 mmol/L) or leading to transfusion ≥2 units whole blood or red cells within 48 hours of the bleed
- surgical bleed that leads to intervention (e.g., re-operation) or has one of: (i) interferes with mobilization; (ii) leads to delayed wound healing; or (iii) leads to deep wound infection
- surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability associated with: (i) drop in hemoglobin ≥20 g/L (1.24 mmol/L); or (ii) transfusion of ≥2 units whole blood or red cells within 48 hours of the bleed
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had an Arterial Thromboembolism (ATE)
Any of the following: stroke, systemic embolism, and/or transient ischemic attack.
- Ischemic stroke: any new focal neurologic deficit that persists for >24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain.
- Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging (e.g., CT angiography).
- Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically <1 hour), that occurs with no evidence of acute infarction on CT/MRI of brain.
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Secondary outcomes (5)
Number of patients who died
Death due to any cause.
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had a Clinically Relevant Non-Major Bleed
any overt bleeding not satisfying the criteria for major bleeding but considered clinically important with one or more of the following criteria met:
- Requires minimal medical intervention (blood in urine or stool that is ongoing and requires a sigmoidoscopy, cystoscopy, CBI etc.) by a healthcare professional
- Lead to hospitalization or increased level of care
- Prompted a face-to-face (ie. not telephone, electronic) evaluation by a physician (this does not include visits prompted by pain, infection, other symptoms etc.)
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had a Minor Bleed
Any overt bleeding not satisfying the criteria for major and clinically relevant non-major bleeding.
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had a Venous Thromboembolism (VTE)
Any of the following: symptomatic deep vein thrombosis and/or pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram).
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had an Acute Coronary Syndrome
Symptomatic myocardial ischemia, defined by pre-specified clinical and objective EKG- and/or troponin-related criteria.
Measured: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start9 Jan 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients taking apixaban, dabigatran, or rivaroxaban will be randomly assigned to follow 1) PAUSE or 2) ASRA perioperative DOAC management.
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, James Douketis, McMaster University
- Investigators
- James D Douketis, MD, Principal investigator, McMaster University/St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192552
- Sponsor's protocol ID
- PAUSE-2-PILOT-2019
- Acronym
- PAUSE2rctP
- Status last verified
- Jan 2020
- First submitted
- 20 Nov 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Anticoagulant (Dabigatran, Rivaroxaban, or Apixaban) Use for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF) Part 2 Randomized Control Trial Pilot
- ClinicalTrials.gov ID
- NCT04192552
- Acronym / sponsor ID
- PAUSE2rctP / PAUSE-2-PILOT-2019
- Conditions
- Atrial Fibrillation
- Keywords
- anticoagulant, atrial fibrillation, surgery, oral anticoagulant, high risk, blood thinner, DOAC, interruption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, St. Joseph's Healthcare Hamilton
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 10 Dec 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.
The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC) and require an elective surgery/procedure. PAUSE did not address safe management of patients having a high-bleed-risk surgery/neuraxial anesthesia in whom there is concern about bleeding, especially neuraxial-related epidural hematomas that can lead to paralysis; such patients are often managed by the approach recommended by the American Society of Regional Anesthesia (ASRA). In PAUSE-2, investigators will test the hypothesis: (i) for patients having a high-bleed-risk surgery/neuraxial anesthesia, the simpler "PAUSE management" is as safe (non-inferior) to the more complex "ASRA management". PAUSE-2 will establish a standard for perioperative DOAC management in patients having high-bleed-risk surgery or neuraxial anesthesia.
To start, this will be a pilot study of a larger PAUSE-2-RCT. The investigators will be conducting this pilot study to assess the feasibility of the study at this smaller scale.
Detailed description
The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018 and presented at the American Society of Hematology Conference on December 4, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC) (apixaban, dabigatran or rivaroxaban) and require an elective surgery/procedure. Standardized, DOAC-specific perioperative management is needed to: (i) minimize patient harm related to serious perioperative adverse events, comprising arterial thromboembolism (A-TE) and major bleeding (MB); and (ii) allow consistent, cost-efficient management that avoids cancelled surgeries/procedures and the need to reverse DOACs. PAUSE did not address safe management of patients having a high-bleed-risk surgery/neuraxial anesthesia in whom there is concern about bleeding, especially neuraxial-related epidural hematomas that can lead to paralysis; such patients are often managed by the approach recommended by the American Society of Regional Anesthesia (ASRA).
In PAUSE-2, the primary question is: (i) In patients having a high-bleed-risk surgery/neuraxial anesthesia, is the simple, shorter-DOAC-interruption PAUSE management as safe as the more complex, longer-interruption ASRA approach? Hypothesis: PAUSE management is non-inferior to ASRA management with expected perioperative risks in both groups of 2.5% for MB (2% non-inferiority margin) and 0.5% for A-TE (1% non-inferiority margin).
In PAUSE-2, the secondary question is: (i) are the PAUSE and ASRA management approaches associated with similar proportions of patients with minimal-to-no residual DOAC levels at surgery, and similar adherence to the DOAC interruption/resumption protocols? Exploratory postulate: PAUSE and ASRA approaches will have similar proportion of patients (±5%) with DOAC levels (<30, 30-49.9, and ≥50 ng/mL), and protocol adherence to perioperative DOACs interrupted and resumed.
Approximately 201 patients will be recruited for the PAUSE-2 Study pilot. This is 10% of the proposed main study (2,010 participants).
In all patients, a 5 mL blood sample will be taken just before surgery (but will be not available for clinical use and cannot be used for genetic testing). Plasma will be frozen and stored at each clinical site before shipment to the core laboratory at McMaster University for storage and standardized DOAC level measurement.
A focused patient enrolled before the procedure and followed up every week up to completion of their participation at 4 weeks (±5 days). Patients will be enrolled over a 1 year period.
To start, this will be a pilot study of a larger PAUSE-2-RCT. Conducting this pilot study will help assess the feasibility and methodology of the study at this smaller scale. It is important to evaluate the feasibility of recruitment, randomization and retention. As well, investigators need to assess the methodology and implementation of the randomized trial.
Note that the outcome for the pilot study is not to evaluate the safety of the perioperative procedure, but to examine the approach to be used in the intended larger study. The outcomes for the larger study will still be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients taking apixaban, dabigatran, or rivaroxaban will be randomly assigned to follow 1) PAUSE or 2) ASRA perioperative DOAC management.
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Active comparator | Other: PAUSE Perioperative DOAC Management, Other: ASRA Perioperative DOAC ManagementPatients currently taking apixaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia. |
| Dabigatran | Active comparator | Other: PAUSE Perioperative DOAC Management, Other: ASRA Perioperative DOAC ManagementPatients currently taking dabigatran that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia. |
| Rivaroxaban | Active comparator | Other: PAUSE Perioperative DOAC Management, Other: ASRA Perioperative DOAC ManagementPatients currently taking rivaroxaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (age ≥18 years) with AF/flutter who is receiving a DOAC: apixaban 2.5 mg or 5 mg BID; dabigatran 110 mg or 150 mg BID; or rivaroxaban 15 mg or 20 mg QD.
- Undergoing an elective surgery/procedure associated with a high-bleed-risk or any surgery/procedure requiring neuraxial anesthesia (includes regional blocks)
- Patient and their clinician are willing to adhere to DOAC interruption/continuation protocols.
- Patient to resume DOAC after surgery/procedure (i.e., no intent to discontinue DOAC).
Key exclusion criteria (6 listed)
- Creatinine clearance (CrCl) <30 mL/min (dabigatran, rivaroxaban) and <25 mL/min (apixaban) based on the Cockroft-Gault equation, which is recommended for DOAC dosing.
- Patient taking a DOAC that is infrequently used (i.e., edoxaban, <5% Canadian DOAC market share in 2018) or is not available for clinical use in Canada or Europe (i.e., betrixaban).
- Patient taking a DOAC for a non-AF clinical indication (excluded to maintain study population homogeneity).
- Cognitive impairment or psychiatric illness that precludes collection of follow-up data.
- Inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| PAUSE Perioperative DOAC ManagementApixaban \& Rivaroxaban: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure. Dabigatran (see below): CrCl ≥50: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure. CrCl <50: Hold DOAC for 4 days before procedure. Re-start DOAC 2+ days post-procedure. | Other | Apixaban, Dabigatran, Rivaroxaban |
| ASRA Perioperative DOAC ManagementApixaban \& Rivaroxaban: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure. Dabigatran (see below): CrCl >80: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure. CrCl 50-80: Hold DOAC for 4 days before procedure. Re-start DOAC 1+ days post-procedure. CrCl 30-49: Hold DOAC for 5 days before procedure. Re-start DOAC 1+ days post-procedure. *Low-dose heparin bridging can be used if at high A-TE risk | Other | Apixaban, Dabigatran, Rivaroxaban |
Primary outcome
Number of patients who had a major bleed
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
≥1 of the criteria below: * bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular * non-surgical bleeding causing a drop in hemoglobin ≥20 g/L (1.24 mmol/L) or leading to transfusion ≥2 units whole blood or red cells within 48 hours of the bleed * surgical bleed that leads to intervention (e.g., re-operation) or has one of: (i) interferes with mobilization; (ii) leads to delayed wound healing; or (iii) leads to deep wound infection * surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability associated with: (i) drop in hemoglobin ≥20 g/L (1.24 mmol/L); or (ii) transfusion of ≥2 units whole blood or red cells within 48 hours of the bleed
Number of patients who had an Arterial Thromboembolism (ATE)
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Any of the following: stroke, systemic embolism, and/or transient ischemic attack. * Ischemic stroke: any new focal neurologic deficit that persists for >24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain. * Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging (e.g., CT angiography). * Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically <1 hour), that occurs with no evidence of acute infarction on CT/MRI of brain.
5 secondary outcomes
Number of patients who died
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had a Clinically Relevant Non-Major Bleed
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had a Minor Bleed
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had a Venous Thromboembolism (VTE)
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Number of patients who had an Acute Coronary Syndrome
Time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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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.
Joanne Duncan, MSc contact
James D Douketis, MD principal investigator
McMaster University/St. Joseph's Healthcare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAUSE Perioperative DOAC Management and ASRA Perioperative DOAC Management in people with Atrial Fibrillation, run by McMaster University at 3 sites in Canada.
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 4 inclusion and 6 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Contact James D Douketis, MD (905-522-1155 ext. 36178, jdouket@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who had a major bleed (time frame: Each patient will be followed up every 7 days up to completion at 28 days post procedure date). 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 22 Jan 2020.