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

NCT02885545 | Withdrawn Phase 4 DMC

• 1 other identifier: STOP HARM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Acute Bleeding; Cerebrovascular Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time from randomization to the first occurrence of ischemic stroke

  Approximately 5 years

• Time from randomization to the first occurrence of either ischemic stroke or non-central nervous system arterial embolism

  Approximately 5 years

• Time from randomization to the first occurrence of all-cause mortality

  Approximately 5 years

• Time from randomization to the first occurrence of a life threatening bleed

  Approximately 5 years

• Bleeding directly caused by implantation of Watchman Device

  30 days

Study Arms (2)

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.

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.

Drug: Continued therapy with the prescribed oral anticoagulant

Interventions

Watchman 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

Left atrial appendage occlusion

Continued therapy with the prescribed oral anticoagulant 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)

Also known as: Standard of care

Continuation of prescribed anticoagulant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carlos Morillo, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2016
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

CA (1)