NCT02885545: STOP-HARM

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

Withdrawn Phase 4 Last updated 26 March 2018

What this trial tests

Phase 4 trial testing Watchman in Chronic Kidney Disease. Withdrawn.

Timeline

1 September 2016

Primary endpoint
5 March 2018

5 March 2018

Quick facts

Lead sponsor	Population Health Research Institute
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	1 September 2016
Primary completion	5 March 2018
Estimated completion	5 March 2018
Sites	1 location across Canada

Drugs / interventions tested

• Watchman
• Continued therapy with the prescribed oral anticoagulant — full drug profile →

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
• Acute Bleeding — all drugs for Acute Bleeding →
• Cerebrovascular Stroke — all drugs for Cerebrovascular Stroke →

Sponsor

Population Health Research Institute

Who can join

Adults 18 to 90, any sex, with Chronic Kidney Disease or Acute Bleeding. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline.
   Klijn CJ, Paciaroni M, Berge E, Korompoki E, et al · · 2019 · cited 135× · PMID 31984228 · DOI 10.1177/2396987319841187
2. Ten tips to manage oral anticoagulation in hemodialysis patients with atrial fibrillation.
   Heine GH, Schneppe C, Bauersachs R, Eitel I, et al · · 2024 · cited 7× · PMID 39439440 · DOI 10.1093/ckj/sfae270
3. Treatment strategies of the thromboembolic risk in kidney failure patients with atrial fibrillation.
   Genovesi S, Camm AJ, Covic A, Burlacu A, et al · · 2024 · cited 5× · PMID 38816212 · DOI 10.1093/ndt/gfae121
4. Atrial Fibrillation in Kidney Failure: Challenges in Risk Assessment and Anticoagulation Management.
   Law MM, Tan SJ, Wong MCG, Toussaint ND. · · 2023 · cited 2× · PMID 37547561 · DOI 10.1016/j.xkme.2023.100690
5. Left Atrial Appendage Occlusion in Patients Receiving Hemodialysis: A Viable Approach to Stroke Prevention?
   Mills MT, Gupta D. · · 2025 · cited 1× · PMID 39896247 · DOI 10.1016/j.jacasi.2024.11.014