Adenosine-induced Myocardial Blood Flow in Peripheral Artery Disease Patients (PAD)
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|ClinicalTrials.gov Identifier: NCT02121288|
Recruitment Status : Withdrawn
First Posted : April 23, 2014
Last Update Posted : October 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease Vascular Disease Arterial Occlusion Disease Intermittent Claudication Ankle Brachial Index (0.9 or Less)||Drug: Ticagrelor Drug: clopidogrel||Phase 4|
The effects of ticagrelor and clopidogrel on adenosine-induced myocardial blood flow (MBF) will be evaluated by cardiac 13N- ammonia positron emission tomography (PET) at rest (baseline), acute dosing on Day 1, and at short term dosing on Day 7.
Subjects receiving ticagrelor will have additional pharmacokinetic (PK) blood samples collected at specific time points to measure ticagrelor concentration in the blood. Subjects' participation will be approximatetly 6 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Parallel, Multi-Center, Phase IV Study to Assess the Effect of Ticagrelor vs Clopidogrel on Adenosine-Induced Myocardial Blood Flow in Peripheral Artery Disease (PAD)Patients|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
oral ticagrelor 90 mg (yellow) tablet
Day 1: Loading dose of ticagrelor 180mg (two 90mg tablets) followed by 90mg dose at 12 hours after loading dose. Subject continues to take ticagrelor 90mg twice a day (morning and evening) for 7 days until next visit (Day 7).
Other Name: Brilinta
Active Comparator: Clopidogrel
oral clopidogrel 75 mg (pink) tablet
Day 1: Clopidogrel 75mg oral tablet. Subjects will continue to take clopidogrel 75mg once a day for 7 days until next visit (Day 7/Visit 3). Note: no loading dose is given for the clopidogrel as those subjects are already on chronic dosing.
Other Name: Plavix
- Assessment of ticagrelor when compared to clopidogrel on adenosine-induced myocardial blood flow (MBF) by cardiac 13N ammonia Positron EmissionTomography (PET) at Visit 2 [ Time Frame: Visit 2 (Day 1): 1 day treament visit ]Assess the acute treatment effects on the 13N-ammonia PET measure and evaulate if they can be correlated with plasma exposure of ticagrelor and or its active metabolite. Subjects will recieve 180mg ticagrelor loading dose or no loading dose for clopidogrel arm, since those subjects are already on chronic dosing. Subjects will undergo additional adenosine-PET at 2 hours following ticagrelor or 4 hours following clopidogrel administration to ascertain MBF.
- Assessment of ticagrelor when compared to clopidogrel on adenosine-induced myocardial blood flow (MBF) by cardiac 13N ammonia Positron EmissionTomography (PET) at Vist 3 [ Time Frame: Visit 3 (Day 7): occurs 7 days after Visit 2 ]Assess the short-term treatment effects on the 13N-ammonia PET measure and evaulate if they can be correlated with plasma exposure of ticagrelor and or its active metabolite. The same sequence described at Visit 2 will be repeated during Visit 3.
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): NCT02121288
|Principal Investigator:||Matthew Budoff, MD||Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center|
|Principal Investigator:||Gabriel Vorobiof, MD||UCLA David Geffen School of Medicine|