GastroIntestinal BleedingPANTHER-GINCT05290857
Anticoagulation After GI Bleeding Pilot Study and Registry
A study testing Restart DOAC within 7 days of clinical hemostasis after GI bleeding and Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding in people with GastroIntestinal Bleeding and Anticoagulant-induced Bleeding, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GastroIntestinal Bleeding, Anticoagulant-induced Bleeding
- What is being tested?
- Restart DOAC within 7 days of clinical hemostasis after GI bleeding and Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 31 Mar 2022to Oct 2027
- Phase
- Interventional
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
- All of the following criteria must be met for the patient to be eligible:
- Male or female subjects aged 18 years or older
- Hospitalized with acute major GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (DOAC).
- OAC therapy discontinued for current acute GI bleed
- Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHADS65 ≥ 1 OR CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)
Who cannot join
- Bleeding from esophageal varices
- Low risk peptic ulcers (Forest IIc or III)
- Mechanical heart valve
- GI bleeding managed surgically (e.g. gastrectomy, colectomy)
- Active gastrointestinal cancer (defined as per ISTH criteria)
- Life expectancy from other causes of less than 3 months
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- Platelet count < 50,000/µL (or < 50x109/L)
- Renal dysfunction (Creatine Clearance <15 mL/min as calculated by the Cockcroft-Gault formula)
- Unable or unwilling to provide informed consent and/or comply with follow-up requirements outlined within the consent form
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Alberta Health Services - Peter Lougheed Center Endoscopy Unit
Calgary, Alberta, T1Y 6J4
Nauzer Forbes, MD, (403) 943-4219, nauzer.forbes@ucalgary.ca
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H8L6
Deborah Siegal, MD, 6137378899 ext. 78804, dsiegal@toh.ca
About this study
Official title: Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)
PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.
Read the detailed description
This pilot cohort management study will evaluate a protocolized strategy for resuming DOACs after major GI bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. The timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.
- Being tested
- Restart DOAC within 7 days of clinical hemostasis after GI bleeding, Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restart DOAC within 7 days of clinical hemostasis after GI bleedingOther
In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team).
High thrombotic risk includes the following:
(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator
Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleedingOther
In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team).
Moderate thrombotic risk includes the following:
(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months
The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.
| Study group | Role | What they receive |
|---|---|---|
| High thrombotic risk | Experimental | For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding. Receives: Other: Restart DOAC within 7 days of clinical hemostasis after GI bleeding |
| Moderate thrombotic risk | Experimental | For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding. Receives: Other: Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The pilot study will be considered a success and to have demonstrated feasibility if average recruitment of 2 patients per month at each site is achieved.
Measured: 18 months
Total recruitment
Feasibility criterion of achieving recruitment of 85% of the target sample size of 100 patients
Measured: 18 months
Secondary outcomes (14)
eligibility
proportion of patients screened who are eligible to participate out of all patients screened
Measured: 18 months
consent
proportion of eligible patients who provide consent to participate out of all eligible patients
Measured: 18 months
completion of all required study procedures
proportion of patients who complete all required study procedures out of all enrolled patients
Measured: 18 months
adherence
proportion of patients who adhere to study treatment strategy (i.e. resumed DOAC within the specified timeframe) out of the total number of patients enrolled
Measured: 18 months
repeat endoscopy
proportion of patients with repeat endoscopy for suspected bleeding after index GI bleed out of all enrolled patients
Measured: 90 days
re-hospitalization
number of patients re-hospitalization for GI bleeding after index GI bleed out of all patients enrolled
Measured: 90 days
major bleeding
number of patients with major bleeding (as per International Society on Thrombosis and Haemostasis [ISTH] criteria) out of all patients enrolled
Measured: 90 days
clinically relevant non-major bleeding
number of patients with clinically relevant non-major bleeding (CRNMB; as per ISTH) out of all patients enrolled
Measured: 90 days
acute ischemic stroke, transient ischemic attack or systemic embolism
number of patients who experience composite of acute ischemic stroke, transient ischemic attack or systemic embolism our of all patients enrolled
Measured: 90 days
acute symptomatic VTE
number of patients with acute objectively confirmed venous thromboembolism (symptomatic proximal lower extremity deep vein thrombosis [DVT], symptomatic pulmonary embolism [PE] as per ISTH) out of all patients enrolled
Measured: 90 days
net clinical benefit outcome rate
number of patients experiencing composite of stroke, systemic embolic event, major bleeding, or death from any cause out of all patients enrolled
Measured: 90 days
all-cause mortality
number of patients who die of all causes out of all patients enrolled
Measured: 90 days
functional status
Change in functional status measured using Standard Assessment of Global Activities in the Elderly (SAGE) scale at 90 days compared to baseline.
SAGE is a 15-item scale that represents a measure of activities of daily living (ADL) across the spectrum of functioning (cognitive, instrumental and basic ADL). The SAGE is supplemented with additional measures of cognition, mood, and quality of life.
The minimum SAGE score - which corresponds to no functional impairments - is 0. The maximum SAGE score - which corresponds to severe global functional impairment - is 45.
Measured: 90 days
Quality of life of Panther GI Research participants
Quality of life measured using EuroQol-5D [EQ-5D®] at 90 days compared to baseline.
The EQ-5D instrument comprises a descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a descriptive profile of a respondent's health state representing the level of reported problems on each of the five dimensions of health (mobility, self-care, usual activities, pain or discomfort, anxiety/depression) that can be converted into a single index value. Average index values (expressed as mean and standard deviation or median and interquartile range depending on skewness) at 90 days will be compared to baseline.
The EQ VAS elicits an individual's rating of their own overall current health (0-100 scale where 0 is the worst health you can imagine and 100 is best health you can imagine). Average EQ VAS ratings (expressed as mean and standard deviation or median and interquartile range depending on skewness) at 90 days will be compared to baseline.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start31 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroIntestinal BleedingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, cohort management study and parallel registry
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah M Siegal, MD MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290857
- Sponsor's protocol ID
- 3349 20210798-01H
- Acronym
- PANTHER-GI
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No