Overview

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

Status:
Withdrawn

Trial end date:
2018-03-05

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Population Health Research Institute

Treatments:

Anticoagulants

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