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Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia (RIVAL-PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260622
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : November 22, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Critical Limb Ischemia
Interventions Drug: rivaroxaban plus aspirin
Drug: clopidogrel plus aspirin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Period Title: Overall Study
Started 11 9
Completed 11 9
Not Completed 0 0
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin Total
Hide Arm/Group Description

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
74.8
(55 to 84)
59.5
(54 to 82)
67
(54 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
4
  36.4%
4
  44.4%
8
  40.0%
Male
7
  63.6%
5
  55.6%
12
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  11.1%
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
11
 100.0%
8
  88.9%
19
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Reintervention, Above Ankle Amputation and Restenosis (RAS)
Hide Description The primary outcome is a combined endpoint consisting of any Reintervention (surgical procedures to revascularize), Above ankle amputation and restenosis(recurrence of blockage in the vein) (RAS) at one year
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
7
  63.6%
4
  44.4%
2.Secondary Outcome
Title Number of Participants With 2 Class Improvement on the Rutherford Scale
Hide Description

Clinical improvement defined as cumulative improvement of 2 classes of the Rutherford scale without the need for repeated TLR in surviving patients.

There are seven stages to consider. the lower the score the less severe the disease or condition.

Rutherford Scale:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
5
  45.5%
8
  88.9%
3.Secondary Outcome
Title Event-free Survival
Hide Description Event-free survival How long a patient is alive without the need for any further intervention or vascular events.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
4
  36.4%
4
  44.4%
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival. How long a patient is alive following the intervention.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
9
 100.0%
5.Secondary Outcome
Title The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR)
Hide Description Target lesion revascularization (TLR) between day 1 and final visit
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
1
  11.1%
6.Secondary Outcome
Title TVR
Hide Description Target vessel revascularization (TVR between day 1 and final visit)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
1
  11.1%
7.Secondary Outcome
Title Peri-procedure Death
Hide Description The number of patients that die within 30 days of the revascularization procedure.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title MACE
Hide Description Cumulative rate of major adverse cardiovascular events between day 1 and final visit
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Major Bleeding
Hide Description Cumulative rate of major bleeding between day 1 and day 90
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Minor Bleeding
Hide Description Cumulative clinically relevant or minor bleeding between day 1 and day 90
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 11 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  11.1%
11.Secondary Outcome
Title Biomarkers
Hide Description Biological plausibility by measuring coagulation changes and SMC proliferation markers within 7 and 90 days based on the following markers: D-dimer, soluble CD40/44 ligands, and ERK 1/2
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Not performed.
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description:

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From randomization to 12-month follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Hide Arm/Group Description

Clopidogrel 75 mg daily X 90 days plus ASA 81 mg daily

clopidogrel plus aspirin: Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days

Rivaroxaban 2.5 mg BID X 90 days plus ASA 81 mg daily

rivaroxaban plus aspirin: Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days

All-Cause Mortality
Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clopidogrel Plus Aspirin Rivaroxaban Plus Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      4/9 (44.44%)    
Blood and lymphatic system disorders     
Minor Bleed - not clinically relevant   0/11 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders     
Diarrhea   0/11 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Headache   0/11 (0.00%)  0 1/9 (11.11%)  1
Investigations     
Abnormal Lab Result   1/11 (9.09%)  1 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Leg injury   1/11 (9.09%)  1 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Penny Phillips
Organization: Ottawa Hospital Research Institute
Phone: 613-737-8899
EMail: pphillips@ohri.ca
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02260622    
Other Study ID Numbers: 20130484-01H
First Submitted: October 6, 2014
First Posted: October 9, 2014
Results First Submitted: November 4, 2019
Results First Posted: November 22, 2019
Last Update Posted: December 4, 2019