NCT01690884

Brief Summary

The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 coronary-artery-disease

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

4.4 years

First QC Date

August 27, 2012

Last Update Submit

February 27, 2018

Conditions

Coronary Artery Disease

Keywords

AdenosineTicagrelorMicrodialysis

Outcome Measures

Primary Outcomes (1)

  • Interstitial levels of adenosine

    After each dose of intrabrachial adenosine

Study Arms (3)

Placebo

PLACEBO COMPARATOR

To determine if there is an increase in adenosine interstitial levels in the forearm.

Drug: Adenosine

Dipyridamole

ACTIVE COMPARATOR

To determine if there is an increase in adenosine interstitial levels in the forearm.

Drug: Adenosine

Ticagrelor

EXPERIMENTAL

To determine if there is an increase in adenosine interstitial levels in the forearm.

Drug: Adenosine

Interventions

AdenosineDRUG

Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,

Also known as: Adenocard
DipyridamolePlaceboTicagrelor

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
  • Not taking any regular medications
  • Able to provide signed consent prior to study participation.

You may not qualify if:

  • History of asthma
  • Pregnancy
  • Exposure to an investigational drug in the last 2 months.
  • Known hypersensitivity to study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonomic Dysfunction Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Italo Biaggioni, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Pharmacology

Study Record Dates

First Submitted

August 27, 2012

First Posted

September 24, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

US(1)