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Trial record 61 of 1208 for:    adenosine

Adenosine-induced Myocardial Blood Flow in Peripheral Artery Disease Patients (PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02121288
Recruitment Status : Withdrawn
First Posted : April 23, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 22, 2014
First Posted Date  ICMJE April 23, 2014
Last Update Posted Date October 15, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine-induced Myocardial Blood Flow in Peripheral Artery Disease Patients
Official Title  ICMJE 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
Brief Summary The purpose of the study is to assess the effect of blood flow to the heart when subjects are treated with ticagrelor (Brilinta) or clopidogrel (antiplatelet drugs that stop the blood from clumping together) in patients with Peripheral Artery Disease (PAD).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Artery Disease
  • Vascular Disease
  • Arterial Occlusion Disease
  • Intermittent Claudication
  • Ankle Brachial Index (0.9 or Less)
Intervention  ICMJE
  • Drug: Ticagrelor
    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
  • Drug: clopidogrel
    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
Study Arms  ICMJE
  • Experimental: Ticagrelor
    oral ticagrelor 90 mg (yellow) tablet
    Intervention: Drug: Ticagrelor
  • Active Comparator: Clopidogrel
    oral clopidogrel 75 mg (pink) tablet
    Intervention: Drug: clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2014)
100
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptomatic lower extremity PAD defined by:
  • Symptoms at the time of screening including classic claudication, other exertional leg discomfort associated with physical limitations from PAD, AND Ankle brachial index (ABI) measurement at Visit 1 needs to be < 0.90. OR, Prior lower extremity revascularization for symptomatic and haemodynamically significant PAD greater than 30 days prior to randomisation, irrespective of present leg symptoms and the Ankle Brachial Index (ABI).
  • Male and female ≥ 18 years of age and less than 60 yrs.
  • Subjects must be taking clopidogrel (75mg/day) for at least 30 days prior to entry to study.

Exclusion Criteria:

  • Participation in another clinical study with an investigational product during the last 30 days.
  • History of ACS within the last 1 year.
  • Hypersensitivity or contraindications to clopidogrel or ticagrelor.
  • Need for chronic oral anticoagulant therapy or chronic low- molecular-weight heparin or long-term treatment with fondaparinux, warfarin, apixaban, rivoroxaban, and parenteral anticoagulants such as enoxeparin, and bivalirudin.
  • Life expectancy < 6 months based on investigator's judgment.
  • Planned lower extremity revascularization (surgical or endovascular) in any vascular territory within the next 3 months or with current ischemic ulcers or gangrene.
  • Planned major amputation due to PAD within the next 3 months or major amputation due to PAD within the last 30 days.
  • Subjects who have suffered a stroke during the past 3 months.
  • Dementia likely to jeopardize understanding of information pertinent to study conduct or compliance to study procedures
  • Severe hypertension that may put the subject at risk.
  • Subjects considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree AV block unless already treated with a permanent pacemaker.
  • Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy).
  • Renal failure requiring dialysis
  • A known bleeding diathesis, haemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing
  • History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days (if the surgical wound is judged to be associated with an increased risk of bleeding).
  • History of thrombocytopenia or neutropenia
  • Females of child-bearing potential (i.e., those who are not chemically or surgically sterilized, post-menopausal who are not willing to use an accepted method of treatment OR who have a positive pregnancy test at screening.
  • Concern for inability of the subject to comply with study procedures and/or follow-up (e.g., alcohol or drug abuse).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02121288
Other Study ID Numbers  ICMJE D5135L00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP