Status:
TERMINATED
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
Lead Sponsor:
The Cleveland Clinic
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
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...
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 partici...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02230527
Start Date
October 1 2014
End Date
May 1 2020
Last Update
July 7 2021
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195