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

Study identifier:D5135L00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

Peripheral Artery Disease

Phase

Phase 4

Healthy volunteers

Study drug

Ticagrelor, clopidogrel

Sex

All

Actual Enrollment

100

Study type

Interventional

Age

18 Years - 59 Years

Date

Study Start Date: 01 Dec 2014

Estimated Primary Completion Date: 01 Feb 2016

Estimated Study Completion Date: 01 Feb 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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).

No locations available

Arms	Assigned Interventions
Experimental: Ticagrelor oral ticagrelor 90 mg (yellow) tablet	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
Active Comparator: Clopidogrel oral clopidogrel 75 mg (pink) tablet	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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Contact Backup

Sharen Muldowney, RN BSN

302-885-4295