Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study (STT-CLIPS)
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|ClinicalTrials.gov Identifier: NCT02091921|
Recruitment Status : Unknown
Verified October 2014 by Leonardo Clavijo, University of Southern California.
Recruitment status was: Recruiting
First Posted : March 19, 2014
Last Update Posted : October 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Drug: Ticagrelor||Phase 1 Phase 2|
Study Aim: This pilot study aims to investigate platelet function after switching from clopidogrel to ticagrelor in patients with critical limb ischemia.
Fifty patients with diagnosis of CLI (Rutherford class IV-VI) treated with clopidogrel 75 mg and aspirin 81 mg daily will be tested for inhibition of platelet aggregation using the VerifyNow P2Y12 and VASP assays before and 6±1 hours after their daily clopidogrel dose. All patients will then be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose. For exploratory analysis, patients will be divided in two groups based on the P2Y12 reaction units (PRU): Group 1. High on treatment platelet reactivity on clopidogrel (HPR), defined as P2Y12 reaction units (PRU) ≥235 and Group 2. Appropriate platelet inhibition on clopidogrel (API), defined as P2Y12 reaction units (PRU) <235.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||September 2016|
All subjects will receive study drug.
All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose.
Other Name: Brilinta
- Increased platelet inhibition [ Time Frame: 2 weeks ]Platelet inhibition will be measured before and after switching for two weeks from clopidogrel to ticagrelor in patients with CLI.
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): NCT02091921
|Contact: Christine Tam, RNemail@example.com|
|Contact: Jorge Caro, MPH||323-382-7646||Jorge.Caro@med.usc.edu|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Christine Tam, RN 323-442-6863 firstname.lastname@example.org|
|Principal Investigator: Leonardo Clavijo, MD, PhD|