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

NCT ID: NCT02885545

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-03-05

Brief 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.

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.

Conditions

Chronic Kidney Disease; Acute Bleeding; Cerebrovascular Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Left atrial appendage occlusion

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.

Group Type: EXPERIMENTAL

Watchman

Intervention Type: DEVICE

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

Continuation of prescribed anticoagulant

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.

Group Type: ACTIVE_COMPARATOR

Continued therapy with the prescribed oral anticoagulant

Intervention Type: DRUG

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)

Interventions

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

Intervention Type: DEVICE

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)

Intervention Type: DRUG

Other Intervention Names

Standard of care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Morillo, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

STOP HARM

Identifier Type: -

Identifier Source: org_study_id