Adenosine-induced Myocardial Blood Flow in Peripheral Artery Disease Patients

NCT02121288 | Withdrawn Phase 4

• 1 other identifier: D5135L00001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Peripheral Artery Disease; Vascular Disease; Arterial Occlusion Disease; Intermittent Claudication; Ankle Brachial Index (0.9 or Less)

Keywords

Peripheral Artery Disease; Myocardial Blood Flow; Cardiac Blood Flow

Outcome Measures

Primary Outcomes (1)

• Assessment of ticagrelor when compared to clopidogrel on adenosine-induced myocardial blood flow (MBF) by cardiac 13N ammonia Positron EmissionTomography (PET) at Visit 2

  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.

  Visit 2 (Day 1): 1 day treament visit

Secondary Outcomes (1)

• Assessment of ticagrelor when compared to clopidogrel on adenosine-induced myocardial blood flow (MBF) by cardiac 13N ammonia Positron EmissionTomography (PET) at Vist 3

  Visit 3 (Day 7): occurs 7 days after Visit 2

Study Arms (2)

Ticagrelor

EXPERIMENTAL

oral ticagrelor 90 mg (yellow) tablet

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

oral clopidogrel 75 mg (pink) tablet

Drug: clopidogrel

Interventions

Ticagrelor DRUG

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).

Also known as: Brilinta

Ticagrelor

clopidogrel DRUG

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.

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Diseases; Intermittent Claudication

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Matthew Budoff, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Gabriel Vorobiof, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 23, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 15, 2014

Record last verified: 2014-10