Critical Limb Ischemia Clinical Trial
Official title:
A Phase 2, Open Label, Pilot Study to Examine the Use of Rivaroxaban Plus Aspirin vs. Clopidogrel Plus Aspirin for the Prevention of Restenosis After Infrainguinal Percutaneous Transluminal Angioplasty for Critical Limb Ischemia
Background: Up to 10% of patients with peripheral arterial disease (PAD) will develop
critical limb ischemia (CLI) which is a decrease of blood flow in the arteries of the limb.
CLI results in resting pain, ulcers, gangrene, and limb loss. The outcome for patients with
CLI is poor. Within 3 months of onset, 12% of patients will require an amputation (removal of
part of the limb) and 9% will die of major cardiovascular events (heart attack or stroke).
Percutaneous angioplasty (PTA), a procedure used to open the blockages in blood flow, has
become the first-line treatment for CLI given its effectiveness, lower cost, and lower risk
of complications. However, 40% of patients will have re-narrowing of the arteries
(restenosis) following the PTA procedure. This is thought to happen in part due to build up
of blood cells called platelets which can also lead to the formation of blood clots. In order
to try to avoid this problem, most patients are prescribed a combination of two blood
thinning medications, acetylsalicylic acid (ASA or aspirin) and clopidogrel (the brand name
is Plavix).
The purpose of this study is to determine if a new blood thinner called rivaroxaban, given in
combination with aspirin, would be more effective in preventing re-narrowing of the arteries
than the current standard of care (aspirin and clopidogrel).
Rivaroxaban is a pill and does not require blood test monitoring. It has been approved by
Health Canada for use in prevention of blood clots in patients undergoing hip or knee surgery
and to treat patients with blood clots in their legs and lungs. Low dose aspirin has been
approved for reducing the risk of heart attacks and strokes. These medications have not been
tested together in patients for prevention of re-narrowing of their arteries
This is a pilot study conducted at one center, The Ottawa Hospital.
It is a Phase 2 open label randomized controlled trial.
Following the PTA procedure, once all inclusion/exclusion criteria are met, the participant
will be randomized into one of two groups:
1. Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily OR
2. Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily
Visits will occur at 7 days, 30 days, 90 days, 6 months and 12 months. Participants will be
followed for 12 months (± 14 days) in total. All adverse events will be collected for the
duration of the study.
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