Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02260622
• Date of registration: 06/10/2014
• Prospective Registration: No
• Primary sponsor: Ottawa Hospital Research Institute
• Public title: Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia RIVAL-PAD
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02260622
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Esteban Gandara, MD
• Affiliation: Ottawa Hospital Research Institute

• Name: Prasad Jetty, MD
• Affiliation: Ottawa Hospital Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent.

2. Infra-inguinal PAD presenting as CLI defined as a Rutherford category of 3, 4, or 5

3. More than 50% stenosis in the target infrainguinal vessel

4. Good candidates for PTA using POBA (plain old balloon angioplasty) with or without
stenting defined as TASC a and b lesions.

Exclusion Criteria:

1. Rutherford scale of 0,1,2 or 6

2. Acute limb-threatening ischemia (e.g. embolic disease)

3. Previous infrainguinal bypass or PTA procedures of the affected leg

4. Hybrid procedures

5. Creatinine clearance <30 mL/min

6. Platelet count <100x109/L

7. INR >1.5; Hbg <100 g/L

8. History of or condition associated with increased bleeding risk including, but not
limited to:

1. Major surgical procedure or trauma within 30 days before the randomization visit

2. Clinically significant gastrointestinal bleeding within 6 months before the
randomization visit

3. History of intracranial, intraocular, spinal, or atraumatic intra-articular
bleeding

4. Chronic hemorrhagic disorder

5. Known intracranial neoplasm, arteriovenous malformation, or aneurysm

6. Sustained uncontrolled hypertension: systolic blood pressure =180 mmHg or
diastolic blood pressure =100 mmHg

9. Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months
or any stroke within 14 days before the randomization visit

10. Aspirin in combination with thienopyridines within 5 days before randomization

11. Intravenous antiplatelets within 5 days before randomization

12. Fibrinolytics within 10 days before randomization

13. Known HIV infection at time of screening

14. Known significant liver disease (e.g., acute clinical hepatitis, chronic active
hepatitis, cirrhosis or ALT >3ULN)

15. Childbearing potential without proper contraceptive measures, pregnancy or breast
feeding

16. Drug addiction or alcohol abuse within 12 months before the randomization visit

17. Systemic treatment with strong CYP 3A4 and P-glycoprotein inhibitors : such as
ketoconazole, itraconazole, posaconazole, or ritonavir

18. Known allergy or hypersensitivity to any component of rivaroxaban, ASA or clopidogrel

19. 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

20. Anticipated need for chronic (> 4 weeks) therapy with non-steroidal anti-inflammatory
drugs.

21. 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.

22. Inability to adhere to protocol.

23. Severe concomitant condition or disease (e.g. life expectancy <6 months secondary to
cancer, advanced liver disease or dementia)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Critical Limb Ischemia

Intervention(s)

Drug: clopidogrel plus aspirin

Drug: rivaroxaban plus aspirin

Primary Outcome(s)

Reintervention, Above Ankle Amputation and Restenosis (RAS) [Time Frame: 1 year]

Secondary Outcome(s)

TVR [Time Frame: 1 year]

Major Bleeding [Time Frame: 90 days]

Overall Survival [Time Frame: 1 year]

The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR) [Time Frame: 1 year]

Biomarkers [Time Frame: 90 days]

MACE [Time Frame: 1 year]

Number of Participants With 2 Class Improvement on the Rutherford Scale [Time Frame: 1 year]

Event-free Survival [Time Frame: 1 year]

Peri-procedure Death [Time Frame: 30 days]

Minor Bleeding [Time Frame: 90 days]

Secondary ID(s)

20130484-01H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Ottawa Hospital

Results

• Results available: Yes
• Date Posted: 22/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02260622