The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial

Chronic Kidney Disease Clinical Trial

— STOP-HARM  

Official title:

The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02885545
• Other study ID #: STOP HARM
• Status: Withdrawn
• Phase: Phase 4
• First received: June 24, 2016
• Last updated: March 26, 2018
• Start date: September 2016
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age =18 years

2. 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

3. History of persistent, paroxysmal or permanent atrial fibrillation documented by ECG within 12 months of randomization

4. High risk of stroke: a. CHADS-VASC=3 or, b. Prior ischemic stroke or TIA 2-24 months prior to randomization,

5. Currently receiving chronic oral anticoagulation (vitamin K antagonist, Apixaban 2.5 mg bid or Rivaroxaban 15mg od) for atrial fibrillation

6. Provides informed consent

Exclusion Criteria:

1. Short life expectancy: a. > 90 years old or, b. Positive "surprise" question (Physician not surprised if patient died in the next 12 months)

2. Stroke within the last 2 months

3. Contraindications to withdrawal of anticoagulation (e.g. mechanical valve, recurrent venous thromboembolism)

4. Contraindication to low-dose aspirin

5. 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

6. Scheduled living related donor transplant

Related Conditions & MeSH terms

• Acute Bleeding
• Cerebrovascular Stroke
• Chronic Kidney Disease
• Hemorrhage
• Kidney Diseases
• Renal Insufficiency, Chronic
• Stroke

Intervention

Device:
• Watchman
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

Drug:
• Continued therapy with the prescribed oral anticoagulant
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)

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 5 years
Secondary	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.	Approximately 5 years
Secondary	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.	Approximately 5 years
Secondary	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.	Approximately 5 years
Secondary	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.	Approximately 5 years
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	Health related quality of life (EQ-5D-5L)	This evaluation will be based on a structured interview with the patient.	Approximately 5 years