Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia
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|ClinicalTrials.gov Identifier: NCT02230527|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 3, 2014
Results First Posted : July 7, 2021
Last Update Posted : July 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: Ticagrelor Drug: Clopidogrel||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2020|
|Actual Study Completion Date :||May 2020|
Active Comparator: Clopidogrel
Clopidogrel 75mg by mouth daily
75mg once a day by mouth
Other Name: Plavix
Ticagrelor 90mg by mouth twice daily
90mg twice a day by mouth
- Absolute Change in TcPO2 From Baseline to Month 6 [ Time Frame: 6 months ]The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230527
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Joseph Campbell, MD||The Cleveland Clinic|