Chronic Kidney DiseasePhase 4STOP-HARMNCT02885545
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
A Phase 4 study testing Watchman and Continued therapy with the prescribed oral anticoagulant in people with Chronic Kidney Disease and Acute Bleeding, run by Population Health Research Institute at 1 site in Canada.
Trial summary
Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high risk for stroke. The use of blood thinking medication in dialysis patients is controversial and warfarin carries a serious risk for major bleeding. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease, Acute Bleeding, Cerebrovascular Stroke
- What is being tested?
- Watchman and Continued therapy with the prescribed oral anticoagulant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to 5 Mar 2018
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Severe chronic kidney disease: a. Receiving dialysis >90 days or b. Estimated glomerular filtration rate less than 30 ml/min/1.73m2 for >90 days as calculated by CKD-Epi
- History of persistent, paroxysmal or permanent atrial fibrillation documented by ECG within 12 months of randomization
- High risk of stroke: a. CHADS-VASC≥3 or, b. Prior ischemic stroke or TIA 2-24 months prior to randomization,
- Currently receiving chronic oral anticoagulation (vitamin K antagonist, Apixaban 2.5 mg bid or Rivaroxaban 15mg od) for atrial fibrillation
- Provides informed consent
Who cannot join
- Short life expectancy: a. > 90 years old or, b. Positive "surprise" question (Physician not surprised if patient died in the next 12 months)
- Stroke within the last 2 months
- Contraindications to withdrawal of anticoagulation (e.g. mechanical valve, recurrent venous thromboembolism)
- Contraindication to low-dose aspirin
- Contraindication to placement of Watchman device: a. Thrombus formation in left atrial appendage b. Severe mitral or aortic valvular disease c. Left atrial appendage diameter too small or too large to accommodate the device d. Pericardial effusion >2 mm e. Cardiac tumor
- Scheduled living related donor transplant
Trial locations and contacts
1 site in 1 country.
About this study
Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high risk for stroke. The use of blood thinking medication in dialysis patients is controversial and warfarin carries a serious risk for major bleeding.
The Watchman device may be an ideal therapy for this population as after implantation it allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.
Read the detailed description
An estimated 25 million North American's have chronic kidney disease (CKD) including 600,000 that require dialysis for end-stage renal disease.The importance of CKD is underscored by the poor survival, frequent hospitalizations and impaired health related quality of life of patients with CKD.
Stroke is an important cause of morbidity, mortality and suffering for patients with CKD. Stroke is approximately 5 to 10 times more common in patients with advanced CKD compared to non-CKD patients. Atrial fibrillation (AF), the most important risk factor for stroke, occurs in up to 20.4% of patients with advanced CKD. Observational studies suggest anywhere from an approximate 56% relative risk reduction to a 2-fold increase in the risk of stroke with warfarin. Furthermore, the risk of bleeding in patients with advanced CKD is roughly 5-fold higher than patients without CKD. Although OAC may not prevent strokes in patients with advanced CKD, it still increases the risk of major bleeding by 1.4 fold.
New stroke prevention strategies in patients with CKD and AF are urgently needed. An effective strategy must reduce the risk of thromboembolic events while not increasing the risk of bleeding substantially. Left atrial appendage occlusion (LAAO) with devices such as the Watchman, represent a unique opportunity to accomplish effective stroke prevention while mitigating the risk of bleeding in this patient population.
- Being tested
- Watchman, Continued therapy with the prescribed oral anticoagulant
- Medical subject headings
- Renal Insufficiency, Chronic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WatchmanDevice
If the patient is randomized to the Intervention Arm of the study the Watchman device will be implanted into the left atrial appendage of the heart
Continued therapy with the prescribed oral anticoagulantDrug
Also called Standard of care
If the patient is randomized to the control arm of the study, they will continue taking the oral anticoagulant that has been prescribed (vitamin K antagonist, Apixiban 2.5mg bid or Rivaroxaban 15mg od)
| Study group | Role | What they receive |
|---|---|---|
| Left atrial appendage occlusion | Experimental | Patients receiving the Watchman device will have it placed via a percutaneous trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance. Patients will be anticoagulated for at least 45 days after the procedure. Receives: Device: Watchman |
| Continuation of prescribed anticoagulant | Active comparator | Patients continuing medical therapy will continue to take their previously prescribed oral anticoagulation (vitamin K antagonist, apixiban or rivaroxaban) for the duration of the study unless a medical reason to alter therapy occurs. Receives: Drug: Continued therapy with the prescribed oral anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to the first occurrence of major bleeding.
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: Approximately 5 years
Secondary outcomes (7)
Time from randomization to the first occurrence of ischemic stroke
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: Approximately 5 years
Time from randomization to the first occurrence of either ischemic stroke or non-central nervous system arterial embolism
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: Approximately 5 years
Time from randomization to the first occurrence of all-cause mortality
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: Approximately 5 years
Time from randomization to the first occurrence of a life threatening bleed
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: Approximately 5 years
Bleeding directly caused by implantation of Watchman Device
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: 30 days
Device complications directly caused by implantation of Watchman Device
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
Measured: 30 days
Health related quality of life (EQ-5D-5L)
This evaluation will be based on a structured interview with the patient.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startSep 2016 (estimated)
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Why it stopped: Failure to recruit any participants in more than one year of recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Morillo, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885545
- Sponsor's protocol ID
- STOP HARM
- Acronym
- STOP-HARM
- Status last verified
- Mar 2018
- First submitted
- 24 Jun 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
- ClinicalTrials.gov ID
- NCT02885545
- Acronym / sponsor ID
- STOP-HARM / STOP HARM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to recruit any participants in more than one year of recruiting.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- Sep 2016 (estimated)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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.
Patients with severe chronic kidney disease (CKD) who develop atrial fibrillation are at high risk for stroke. The use of blood thinking medication in dialysis patients is controversial and warfarin carries a serious risk for major bleeding.
The Watchman device may be an ideal therapy for this population as after implantation it allows for the discontinuation of blood thinners, thereby reducing the risk of bleeding.
Detailed description
An estimated 25 million North American's have chronic kidney disease (CKD) including 600,000 that require dialysis for end-stage renal disease.The importance of CKD is underscored by the poor survival, frequent hospitalizations and impaired health related quality of life of patients with CKD.
Stroke is an important cause of morbidity, mortality and suffering for patients with CKD. Stroke is approximately 5 to 10 times more common in patients with advanced CKD compared to non-CKD patients. Atrial fibrillation (AF), the most important risk factor for stroke, occurs in up to 20.4% of patients with advanced CKD. Observational studies suggest anywhere from an approximate 56% relative risk reduction to a 2-fold increase in the risk of stroke with warfarin. Furthermore, the risk of bleeding in patients with advanced CKD is roughly 5-fold higher than patients without CKD. Although OAC may not prevent strokes in patients with advanced CKD, it still increases the risk of major bleeding by 1.4 fold.
New stroke prevention strategies in patients with CKD and AF are urgently needed. An effective strategy must reduce the risk of thromboembolic events while not increasing the risk of bleeding substantially. Left atrial appendage occlusion (LAAO) with devices such as the Watchman, represent a unique opportunity to accomplish effective stroke prevention while mitigating the risk of bleeding in this patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left atrial appendage occlusion | Experimental | Device: WatchmanPatients receiving the Watchman device will have it placed via a percutaneous trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance. Patients will be anticoagulated for at least 45 days after the procedure. |
| Continuation of prescribed anticoagulant | Active comparator | Drug: Continued therapy with the prescribed oral anticoagulantPatients continuing medical therapy will continue to take their previously prescribed oral anticoagulation (vitamin K antagonist, apixiban or rivaroxaban) for the duration of the study unless a medical reason to alter therapy occurs. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Severe chronic kidney disease: a. Receiving dialysis >90 days or b. Estimated glomerular filtration rate less than 30 ml/min/1.73m2 for >90 days as calculated by CKD-Epi
- History of persistent, paroxysmal or permanent atrial fibrillation documented by ECG within 12 months of randomization
- High risk of stroke: a. CHADS-VASC≥3 or, b. Prior ischemic stroke or TIA 2-24 months prior to randomization,
- Currently receiving chronic oral anticoagulation (vitamin K antagonist, Apixaban 2.5 mg bid or Rivaroxaban 15mg od) for atrial fibrillation
Key exclusion criteria (6 listed)
- Short life expectancy: a. > 90 years old or, b. Positive "surprise" question (Physician not surprised if patient died in the next 12 months)
- Stroke within the last 2 months
- Contraindications to withdrawal of anticoagulation (e.g. mechanical valve, recurrent venous thromboembolism)
- Contraindication to low-dose aspirin
- Contraindication to placement of Watchman device: a. Thrombus formation in left atrial appendage b. Severe mitral or aortic valvular disease c. Left atrial appendage diameter too small or too large to accommodate the device d. Pericardial effusion >2 mm e. Cardiac tumor
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 |
|---|---|---|
| WatchmanIf the patient is randomized to the Intervention Arm of the study the Watchman device will be implanted into the left atrial appendage of the heart | Device | Left atrial appendage occlusion |
| Continued therapy with the prescribed oral anticoagulantAlso: Standard of careIf the patient is randomized to the control arm of the study, they will continue taking the oral anticoagulant that has been prescribed (vitamin K antagonist, Apixiban 2.5mg bid or Rivaroxaban 15mg od) | Drug | Continuation of prescribed anticoagulant |
Primary outcome
Time from randomization to the first occurrence of major bleeding.
Time frame: Approximately 5 years
This evaluation will be based on a structured interview with the patient. In case of positive evaluation for the outcome more information will be obtained by hospital or physician.
7 secondary outcomes
Time from randomization to the first occurrence of ischemic stroke
Time frame: Approximately 5 years
Time from randomization to the first occurrence of either ischemic stroke or non-central nervous system arterial embolism
Time frame: Approximately 5 years
Time from randomization to the first occurrence of all-cause mortality
Time frame: Approximately 5 years
Time from randomization to the first occurrence of a life threatening bleed
Time frame: Approximately 5 years
Bleeding directly caused by implantation of Watchman Device
Time frame: 30 days
Device complications directly caused by implantation of Watchman Device
Time frame: 30 days
Health related quality of life (EQ-5D-5L)
Time frame: Approximately 5 years
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 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Morillo, MD principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Watchman and Continued therapy with the prescribed oral anticoagulant in people with Chronic Kidney Disease and Acute Bleeding, run by Population Health Research Institute at 1 site 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 6 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: withdrawn, as of the sponsor's last update on 29 Mar 2018. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time from randomization to the first occurrence of major bleeding. (time frame: Approximately 5 years). 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 29 Mar 2018.