Back to resultsEstablishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
Primary Purpose
Peripheral Arterial Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks
- Willingness to sign informed consent
- Ability to return for follow up visits
- A female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. Women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). The female patient should not be lactating and must have a negative pregnancy test at screening.
Exclusion Criteria:
Patients will be ineligible for this study if they meet any one of the following criteria:
- Intolerance to thienopyridines
- Hypersensitivity to ticagrelor or any component of the product.
- Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
- History of intracranial hemorrhage
- History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
- Active bleeding
- Allergy to aspirin
- Baseline TcPO2 < 10 mmHg post angiography
- Resting, pre- procedure heart rate <50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
- Severe COPD on home oxygen therapy -
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clopidogrel
Ticagrelor
Arm Description
Clopidogrel 75mg by mouth daily
Ticagrelor 90mg by mouth twice daily
Outcomes
Primary Outcome Measures
Absolute Change in TcPO2 From Baseline to Month 6
The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02230527
Brief Title
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
Official Title
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
October 2014 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.
Detailed Description
Enrollment into the study will require severe symptomatic CLI without wounds (Rutherford Stage IV) or CLI with concomitant vascular insufficiency wounds (Rutherford Stage V-VI PAD).
Potential participants will be identified and screened prior to discharge or at the time of the first out-patient visit (within 2 weeks after discharge) after a percutaneous lower extremity arterial angiography with arterial intervention (stent or balloon angioplasty) for the presence of lower extremity vascular insufficiency. Participants will be classified as Rutherford Class IV - VI (with or without ulcerations). A total of 60 patients will be randomized into 2 treatment groups in a 1:1 ratio (ticagrelor to clopidogrel). Patients are placed on clopidogrel after their arterial intervention per standard of care. They will remain on clopidogrel up to the time that randomization occurs. For patients that are randomized to ticagrelor, the clopidogrel will be stopped.
Patients will be randomized to either ticagrelor 90mg by mouth twice daily or clopidogrel 75mg by mouth daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 75mg by mouth daily
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 90mg by mouth twice daily
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilinta, Brilique, Possia
Intervention Description
90mg twice a day by mouth
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
75mg once a day by mouth
Primary Outcome Measure Information:
Title
Absolute Change in TcPO2 From Baseline to Month 6
Description
The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks
Willingness to sign informed consent
Ability to return for follow up visits
A female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. Women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). The female patient should not be lactating and must have a negative pregnancy test at screening.
Exclusion Criteria:
Patients will be ineligible for this study if they meet any one of the following criteria:
Intolerance to thienopyridines
Hypersensitivity to ticagrelor or any component of the product.
Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
History of intracranial hemorrhage
History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
Active bleeding
Allergy to aspirin
Baseline TcPO2 < 10 mmHg post angiography
Resting, pre- procedure heart rate <50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
Severe COPD on home oxygen therapy -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Campbell, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
We'll reach out to this number within 24 hrs