Status:
COMPLETED
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Ottawa Hospital
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Written informed consent.
- Infra-inguinal PAD presenting as CLI defined as a Rutherford category of 3, 4, or 5
- More than 50% stenosis in the target infrainguinal vessel
- Good candidates for PTA using POBA (plain old balloon angioplasty) with or without stenting defined as TASC a and b lesions.
Exclusion
- Rutherford scale of 0,1,2 or 6
- Acute limb-threatening ischemia (e.g. embolic disease)
- Previous infrainguinal bypass or PTA procedures of the affected leg
- Hybrid procedures
- Creatinine clearance \<30 mL/min
- Platelet count \<100x109/L
- INR \>1.5; Hbg \<100 g/L
- History of or condition associated with increased bleeding risk including, but not limited to:
- Major surgical procedure or trauma within 30 days before the randomization visit
- Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
- History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
- Chronic hemorrhagic disorder
- Known intracranial neoplasm, arteriovenous malformation, or aneurysm
- Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
- Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months or any stroke within 14 days before the randomization visit
- Aspirin in combination with thienopyridines within 5 days before randomization
- Intravenous antiplatelets within 5 days before randomization
- Fibrinolytics within 10 days before randomization
- Known HIV infection at time of screening
- Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT \>3ULN)
- Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
- Drug addiction or alcohol abuse within 12 months before the randomization visit
- Systemic treatment with strong CYP 3A4 and P-glycoprotein inhibitors : such as ketoconazole, itraconazole, posaconazole, or ritonavir
- Known allergy or hypersensitivity to any component of rivaroxaban, ASA or clopidogrel
- Need for long term anticoagulation or double antiplatelet agents other than PAD such as atrial fibrillation, heart valve replacement, acute coronary syndrome, stroke or venous thromboembolism
- Anticipated need for chronic (\> 4 weeks) therapy with non-steroidal anti-inflammatory drugs.
- Concomitant treatment with any other anticoagulant, including oral anticoagulants, such as warfarin, dabigatran, apixaban, except under circumstances of switching therapy to or from study treatment.
- Inability to adhere to protocol.
- Severe concomitant condition or disease (e.g. life expectancy \<6 months secondary to cancer, advanced liver disease or dementia)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02260622
Start Date
October 1 2014
End Date
March 1 2019
Last Update
December 4 2019
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9