Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

NCT ID: NCT01690884

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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The investigators will compare adenosine interstitial levels using a parallel design study with three groups of subjects. Forearm interstitial adenosine levels will be measured at baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the investigators will repeat the dialysate collections at baseline and after adenosine infusions.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Adenosine

Intervention Type DRUG

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,

Dipyridamole

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

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

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,

Ticagrelor

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

Group Type EXPERIMENTAL

Adenosine

Intervention Type DRUG

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,

Interventions

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Adenosine

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,

Intervention Type DRUG

Other Intervention Names

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Adenocard

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of asthma
2. Pregnancy
3. Exposure to an investigational drug in the last 2 months.
4. Known hypersensitivity to study medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Italo Biaggioni

Professor of Medicine and Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Italo Biaggioni, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Autonomic Dysfunction Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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120477

Identifier Type: -

Identifier Source: org_study_id

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